Trial Outcomes & Findings for DTA (Dopaminergic Therapy for Anhedonia) Study (NCT NCT04723147)
NCT ID: NCT04723147
Last Updated: 2024-12-16
Results Overview
Patients will undergo resting-state and task-based functional magnetic resonance imaging (fMRI) to calculate functional connectivity (FC) between the ventral striatum (VS) and ventromedial prefrontal cortex (vmPFC). FC is measured as continuous Z scores reflecting the correlation of activity between the brain regions using Fisher's Z transformation {Z(R)=0.5ln\[(1+R)/(1-R)\]}. This is a standard method for calculating fMRI FC whereby higher FC Z scores reflect stronger connectivity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
Baseline, 1-week of placebo, and 1-week at each dose of L-DOPA (150 mg/day, 300 mg/day and 450 mg/day)
Results posted on
2024-12-16
Participant Flow
38 individuals consented to participate in the study and underwent study-specific screening. 19 of these individuals met eligibility criteria and took part in the study. Only those who actually started the study are included in the following tables.
Participant milestones
| Measure |
Carbidopa Levodopa Followed by Placebo
Participants will receive first Carbidopa Levodopa at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day; and then placebo.
Carbidopa Levodopa: Patients will receive L-DOPA at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA. Starting dose is 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day
Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 1 placebo tablet matching the Carbidopa Levodopa tablet.
|
Placebo Followed by Carbidopa Levodopa
Participants will receive first placebo, and then Carbidopa Levodopa (L-DOPA) at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day.
Carbidopa Levodopa: Patients will receive L-DOPA at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA. Starting dose is 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day
Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 1 placebo tablet matching the Carbidopa Levodopa tablet.
|
|---|---|---|
|
First Intervention
STARTED
|
10
|
9
|
|
First Intervention
COMPLETED
|
10
|
9
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
8
|
|
Second Intervention
COMPLETED
|
10
|
8
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Carbidopa Levodopa Followed by Placebo
n=10 Participants
Participants will receive first Carbidopa Levodopa at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day; and then placebo.
Carbidopa Levodopa: Patients will receive L-DOPA at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA. Starting dose is 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day
Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 1 placebo tablet matching the Carbidopa Levodopa tablet.
|
Placebo Followed by Carbidopa Levodopa
n=9 Participants
Participants will receive first placebo, and then Carbidopa Levodopa (L-DOPA) at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day.
Carbidopa Levodopa: Patients will receive L-DOPA at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA. Starting dose is 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day
Placebo: A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 1 placebo tablet matching the Carbidopa Levodopa tablet.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 9.0 • n=10 Participants
|
39.4 years
STANDARD_DEVIATION 8.6 • n=9 Participants
|
36.7 years
STANDARD_DEVIATION 9.0 • n=19 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
7 Participants
n=9 Participants
|
17 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
9 participants
n=9 Participants
|
19 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1-week of placebo, and 1-week at each dose of L-DOPA (150 mg/day, 300 mg/day and 450 mg/day)Population: Reported sample sizes reflect the number of available and analyzable fMRI scans for each condition from participants having data at baseline and at least one post L-DOPA or post placebo scan
Patients will undergo resting-state and task-based functional magnetic resonance imaging (fMRI) to calculate functional connectivity (FC) between the ventral striatum (VS) and ventromedial prefrontal cortex (vmPFC). FC is measured as continuous Z scores reflecting the correlation of activity between the brain regions using Fisher's Z transformation {Z(R)=0.5ln\[(1+R)/(1-R)\]}. This is a standard method for calculating fMRI FC whereby higher FC Z scores reflect stronger connectivity.
Outcome measures
| Measure |
All Participants
n=17 Participants
Participants that received Carbidopa Levodopa (150, 300, 450 mg/day per week) and Placebo, independent of the order of administration.
* Carbidopa Levodopa at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day.
* Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally. Participants received 1 placebo tablet matching the Carbidopa Levodopa tablet.
|
|---|---|
|
Targeted Ventral Striatum to Ventromedial Prefrontal Cortex (VS-vmPFC) Connectivity
Baseline
|
0.183 Mean subject-level FC Z scores
Standard Deviation 0.132
|
|
Targeted Ventral Striatum to Ventromedial Prefrontal Cortex (VS-vmPFC) Connectivity
Week 1 post- placebo
|
0.219 Mean subject-level FC Z scores
Standard Deviation 0.125
|
|
Targeted Ventral Striatum to Ventromedial Prefrontal Cortex (VS-vmPFC) Connectivity
Week 1 post L-DOPA (150 mg/day)
|
0.275 Mean subject-level FC Z scores
Standard Deviation 0.133
|
|
Targeted Ventral Striatum to Ventromedial Prefrontal Cortex (VS-vmPFC) Connectivity
Week 1 post L-DOPA (300 mg/day)
|
0.202 Mean subject-level FC Z scores
Standard Deviation 0.134
|
|
Targeted Ventral Striatum to Ventromedial Prefrontal Cortex (VS-vmPFC) Connectivity
Week 1 post L-DOPA (450 mg/day)
|
0.287 Mean subject-level FC Z scores
Standard Deviation 0.135
|
SECONDARY outcome
Timeframe: Baseline, 1-week of placebo, and 1-week at each dose of L-DOPA (150 mg/day, 300 mg/day and 450 mg/day)Population: Reported sample sizes reflect the number of participants with available EEfRT data for each condition.
The EEfRT is a widely used, multi-trial task in which participants are given an opportunity on each trial to choose between two different task difficulty levels in order to obtain monetary rewards. EEfRT will be used as an objective measure of motivation and will be administered following MRI scans during the study. The EEfRT is reported as the percent of high effort trials selected. A higher percentage reflects higher motivation for effort expenditure.
Outcome measures
| Measure |
All Participants
n=18 Participants
Participants that received Carbidopa Levodopa (150, 300, 450 mg/day per week) and Placebo, independent of the order of administration.
* Carbidopa Levodopa at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day.
* Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally. Participants received 1 placebo tablet matching the Carbidopa Levodopa tablet.
|
|---|---|
|
Effort-Expenditure for Rewards Task (EEfRT)
Baseline
|
0.369 percentage of choices
Standard Deviation 0.198
|
|
Effort-Expenditure for Rewards Task (EEfRT)
Week 1 post L-DOPA (450 mg/day)
|
0.330 percentage of choices
Standard Deviation 0.154
|
|
Effort-Expenditure for Rewards Task (EEfRT)
Week 1 post-placebo
|
0.300 percentage of choices
Standard Deviation 0.165
|
|
Effort-Expenditure for Rewards Task (EEfRT)
Week 1 post L-DOPA (150 mg/day)
|
0.368 percentage of choices
Standard Deviation 0.145
|
|
Effort-Expenditure for Rewards Task (EEfRT)
Week 1 post L-DOPA (300 mg/day)
|
0.322 percentage of choices
Standard Deviation 0.153
|
SECONDARY outcome
Timeframe: Baseline, 1-week of placebo, and 1-week at each dose of L-DOPA (150 mg/day, 300 mg/day and 450 mg/day)Population: Smaller sample sizes reflect participant withdrawal or incomplete data
Anhedonia symptoms experienced over the past 7 days will be assessed from a subscale of the Inventory of Depressive Symptomatology- Self-Report (IDS-SR), a widely used self-report for measuring depression severity. The anhedonia subscale score is created by summing responses to items #8 (responsiveness of mood to good or desired events), #19 (general interest), and #21 (capacity for pleasure). Total anhedonia subscale scores range from 0-9 with higher scores reflecting greater anhedonia.
Outcome measures
| Measure |
All Participants
n=19 Participants
Participants that received Carbidopa Levodopa (150, 300, 450 mg/day per week) and Placebo, independent of the order of administration.
* Carbidopa Levodopa at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day.
* Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally. Participants received 1 placebo tablet matching the Carbidopa Levodopa tablet.
|
|---|---|
|
Inventory of Depressive Symptomatology- Self-Report (IDS-SR) Anhedonia Scale
Baseline
|
5.2 score on a scale
Standard Deviation 2.0
|
|
Inventory of Depressive Symptomatology- Self-Report (IDS-SR) Anhedonia Scale
Week 1 post-placebo
|
3.0 score on a scale
Standard Deviation 2.1
|
|
Inventory of Depressive Symptomatology- Self-Report (IDS-SR) Anhedonia Scale
Week 1 post L-DOPA (300 mg/day)
|
2.4 score on a scale
Standard Deviation 1.8
|
|
Inventory of Depressive Symptomatology- Self-Report (IDS-SR) Anhedonia Scale
Week 1 post L-DOPA (450 mg/day)
|
3.2 score on a scale
Standard Deviation 1.7
|
|
Inventory of Depressive Symptomatology- Self-Report (IDS-SR) Anhedonia Scale
Week 1 post L-DOPA (150 mg/day)
|
2.5 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, 1-week of placebo, and 1-week at each dose of L-DOPA (150 mg/day, 300 mg/day and 450 mg/day)Population: Smaller sample sizes reflect participant withdrawal or incomplete data
The Snaith-Hamilton Pleasure Scale-Clinician (SHAPS-C) is a clinician-administered version of a validated tool for assessing hedonic tone. The SHAPS-C uses 14 questions. If "Strongly disagree" or "disagree" is chosen as the answer, item receives a score of 1 per question. If "Strongly agree" or "agree" is chosen, item receives a score of 0; then sum the scores. Total possible score ranges from 0 to 14, with higher scores reflecting greater pathology (worse study outcome).
Outcome measures
| Measure |
All Participants
n=19 Participants
Participants that received Carbidopa Levodopa (150, 300, 450 mg/day per week) and Placebo, independent of the order of administration.
* Carbidopa Levodopa at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day.
* Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally. Participants received 1 placebo tablet matching the Carbidopa Levodopa tablet.
|
|---|---|
|
Hedonic Capacity as Measured by the Snaith Hamilton Pleasure Clinician Scale (SHAPS-C )
Week 1 post-placebo
|
5.6 score on a scale
Standard Deviation 5.4
|
|
Hedonic Capacity as Measured by the Snaith Hamilton Pleasure Clinician Scale (SHAPS-C )
Week 1 post L-DOPA (150 mg/day)
|
3.9 score on a scale
Standard Deviation 4.3
|
|
Hedonic Capacity as Measured by the Snaith Hamilton Pleasure Clinician Scale (SHAPS-C )
Week 1 post L-DOPA (300 mg/day)
|
4.9 score on a scale
Standard Deviation 5.1
|
|
Hedonic Capacity as Measured by the Snaith Hamilton Pleasure Clinician Scale (SHAPS-C )
Week 1 post L-DOPA (450 mg/day)
|
5.3 score on a scale
Standard Deviation 5.2
|
|
Hedonic Capacity as Measured by the Snaith Hamilton Pleasure Clinician Scale (SHAPS-C )
Baseline
|
9.7 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline, 1-week of placebo, and 1-week at each dose of L-DOPA (150 mg/day, 300 mg/day and 450 mg/day)Population: Smaller sample sizes reflect participant withdrawal or incomplete data.
The Motivation and Pleasure-Self-Report (MAP-SR) will be used to capture self-reported aspects of anhedonia and reduced motivation. The scale uses 18 question each rated on a Likert scale of 0-4. Total possible score ranges from 18 to 72, with higher scores reflecting worse outcome.
Outcome measures
| Measure |
All Participants
n=19 Participants
Participants that received Carbidopa Levodopa (150, 300, 450 mg/day per week) and Placebo, independent of the order of administration.
* Carbidopa Levodopa at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day.
* Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally. Participants received 1 placebo tablet matching the Carbidopa Levodopa tablet.
|
|---|---|
|
Motivation and Pleasure-Self-Report (MAP-SR)
Baseline
|
22.4 mean MAP-SR total score
Standard Deviation 9.9
|
|
Motivation and Pleasure-Self-Report (MAP-SR)
Week 1 post-placebo
|
35.0 mean MAP-SR total score
Standard Deviation 13.4
|
|
Motivation and Pleasure-Self-Report (MAP-SR)
Week 1 post L-DOPA (150 mg/day)
|
35.4 mean MAP-SR total score
Standard Deviation 7.0
|
|
Motivation and Pleasure-Self-Report (MAP-SR)
Week 1 post L-DOPA (300 mg/day)
|
35.3 mean MAP-SR total score
Standard Deviation 5.2
|
|
Motivation and Pleasure-Self-Report (MAP-SR)
Week 1 post L-DOPA (450 mg/day)
|
33.5 mean MAP-SR total score
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline, 1-week of placebo, and 1-week at each dose of L-DOPA (150 mg/day, 300 mg/day and 450 mg/day)Population: Lower sample sizes reflect participant withdrawal or incomplete data.
The anhedonia and motivation-related item from the clinician administered Hamilton Depression Rating Scale (HAM-D) (item #7: work and activities) will be used to measure anhedonia. This item is rated on a scale of 0-4 with higher scores reflecting worse outcome.
Outcome measures
| Measure |
All Participants
n=19 Participants
Participants that received Carbidopa Levodopa (150, 300, 450 mg/day per week) and Placebo, independent of the order of administration.
* Carbidopa Levodopa at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA with a starting dose of 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day.
* Placebo: A placebo is a sugar pill that has no therapeutic effect and was administered orally. Participants received 1 placebo tablet matching the Carbidopa Levodopa tablet.
|
|---|---|
|
Hamilton Depression Rating Scale (HAM-D) Anhedonia and Motivation Item
Week 1 post L-DOPA (450 mg/day)
|
1.8 score on a scale
Standard Deviation 1.0
|
|
Hamilton Depression Rating Scale (HAM-D) Anhedonia and Motivation Item
Baseline
|
3.0 score on a scale
Standard Deviation 0.3
|
|
Hamilton Depression Rating Scale (HAM-D) Anhedonia and Motivation Item
Week 1 post-placebo
|
1.9 score on a scale
Standard Deviation 1.1
|
|
Hamilton Depression Rating Scale (HAM-D) Anhedonia and Motivation Item
Week 1 post L-DOPA (150 mg/day)
|
1.6 score on a scale
Standard Deviation 1.1
|
|
Hamilton Depression Rating Scale (HAM-D) Anhedonia and Motivation Item
Week 1 post L-DOPA (300 mg/day)
|
1.3 score on a scale
Standard Deviation 0.9
|
Adverse Events
Carbidopa Levodopa, 150 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Carbidopa Levodopa, 300 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Carbidopa Levodopa 450 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carbidopa Levodopa, 150 mg
n=18 participants at risk
Patients received L-DOPA at 150 mg dose administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA.
|
Carbidopa Levodopa, 300 mg
n=18 participants at risk
Patients received L-DOPA at 300 mg dose administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA.
|
Carbidopa Levodopa 450 mg
n=18 participants at risk
Patients received L-DOPA at 450 mg dose administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA.
|
Placebo
n=19 participants at risk
Participants received 1 placebo tablet matching the carbidopa Levodopa tablet.
|
|---|---|---|---|---|
|
Nervous system disorders
Irritability
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Injury, poisoning and procedural complications
Head Laceration
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Gastrointestinal disorders
Mild gas
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.3%
1/19 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Eye disorders
Mild Blurry vision when adjusting to glasses
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.3%
1/19 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Nervous system disorders
Restlessness
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.3%
1/19 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Injury, poisoning and procedural complications
Mild foot injury
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.3%
1/19 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
General disorders
Nose bleed
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.3%
1/19 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Gastrointestinal disorders
Mild Nausea
|
16.7%
3/18 • Number of events 3 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
16.7%
3/18 • Number of events 5 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.3%
1/19 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 3 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
38.9%
7/18 • Number of events 9 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
33.3%
6/18 • Number of events 6 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.3%
1/19 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.3%
1/19 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Nervous system disorders
Paresthesia
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Cardiac disorders
Chest tightness
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Nervous system disorders
Mild Crawling skin sensation
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
General disorders
Insomnia
|
11.1%
2/18 • Number of events 2 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Skin and subcutaneous tissue disorders
Mild bruising of venipuncture
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Injury, poisoning and procedural complications
Mild bruising on arm from workplace accident
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
General disorders
Sinus Congestion
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Renal and urinary disorders
Dysuria
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Injury, poisoning and procedural complications
Nausea and vomiting (Food poisoing)
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
General disorders
Muscle pain (soreness)
|
11.1%
2/18 • Number of events 2 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
11.1%
2/18 • Number of events 2 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Gastrointestinal disorders
Heartburn
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
General disorders
Fatigue
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
11.1%
2/18 • Number of events 2 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
11.1%
2/18 • Number of events 2 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
General disorders
Weight loss
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
General disorders
Decreased Appetite
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
General disorders
Hot Flashes
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Musculoskeletal and connective tissue disorders
Wrist Pain
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Nervous system disorders
Hemiparesthesia with pain
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Psychiatric disorders
Panic Attack during MRI scan
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
General disorders
Soar throat
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Gastrointestinal disorders
Bleeding hemorroid
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
General disorders
Nasal Congestion
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Gastrointestinal disorders
Stomach cramp
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Gastrointestinal disorders
Mild allergic reaction to food
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Musculoskeletal and connective tissue disorders
Mild pain under lower rib cage
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/18 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
5.6%
1/18 • Number of events 1 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
0.00%
0/19 • From time of treatment onset (placebo or carbidopa levodopa) up to 6-weeks post-intervention, about 2 months total
Enrolled participants were monitored closely by study clinicians for any adverse events. If any overt study-related adverse events occur, a decision was made about study continuation. Additionally, a record of adverse events for study participants was reported to the DSMB on a regular basis. Subjects were closely monitored during the course of the study for development of any serious or unexpected adverse reactions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place