Trial Outcomes & Findings for A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease (NCT NCT02577523)
NCT ID: NCT02577523
Last Updated: 2023-05-25
Results Overview
Based on Parkinson's disease symptom assessment, "ON" time is when there is good response to medication and few symptoms. "OFF" time is when no there is no response to medication and significant motor symptoms. An "ON/OFF" Log was completed by a blinded rater starting before the first dose of LD/DDI and following the first dose at 30 min intervals for 8 hrs. The changes in "OFF" time as hours (normalized to 16 hrs of awake time) during the 8 hrs of data collection were estimated. Negative change from baseline for "OFF" time indicates improvement.
COMPLETED
PHASE2
38 participants
Baseline to Day 28
2023-05-25
Participant Flow
Participant milestones
| Measure |
ND0612 (Levodopa/Carbidopa Solution) Dosing Regimen 1
Dosing Regimen 1 of ND0612 (Levodopa/Carbidopa solution) continuous SC infusion over 24 hours
ND0612 (Levodopa/Carbidopa solution, 720/90 mg daily)
|
ND0612 (Levodopa/Carbidopa Solution) Dosing Regimen 2
Dosing Regimen 2 of ND0612 (Levodopa/Carbidopa solution) continuous SC infusion over 14 hours
ND0612 (Levodopa/Carbidopa solution, 538/67 mg daily) + IR-LD/CD (oral Levodopa/Carbidopa, 150/15 mg in the morning)
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
ND0612 (Levodopa/Carbidopa Solution) Dosing Regimen 1
Dosing Regimen 1 of ND0612 (Levodopa/Carbidopa solution) continuous SC infusion over 24 hours
ND0612 (Levodopa/Carbidopa solution, 720/90 mg daily)
|
ND0612 (Levodopa/Carbidopa Solution) Dosing Regimen 2
Dosing Regimen 2 of ND0612 (Levodopa/Carbidopa solution) continuous SC infusion over 14 hours
ND0612 (Levodopa/Carbidopa solution, 538/67 mg daily) + IR-LD/CD (oral Levodopa/Carbidopa, 150/15 mg in the morning)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease
Baseline characteristics by cohort
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 10.1 • n=99 Participants
|
64 years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
63.5 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Modified Hoehn and Yahr Stage
1
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Modified Hoehn and Yahr Stage
1.5
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Modified Hoehn and Yahr Stage
2
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Modified Hoehn and Yahr Stage
2.5
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Modified Hoehn and Yahr Stage
3
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Time since Parkinson's disease diagnosis
|
10.7 Years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
12.2 Years
STANDARD_DEVIATION 5 • n=107 Participants
|
11.5 Years
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Time since motor fluctuations
|
5.7 Years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
5.5 Years
STANDARD_DEVIATION 4.8 • n=107 Participants
|
5.6 Years
STANDARD_DEVIATION 5.9 • n=206 Participants
|
|
Time since dyskinesia onset
|
3.1 years
STANDARD_DEVIATION 2.7 • n=99 Participants
|
4.2 years
STANDARD_DEVIATION 3.4 • n=107 Participants
|
3.7 years
STANDARD_DEVIATION 3.1 • n=206 Participants
|
|
Daily "OFF" time
|
5.6 Hours
STANDARD_DEVIATION 2.1 • n=99 Participants
|
5.0 Hours
STANDARD_DEVIATION 2.4 • n=107 Participants
|
5.3 Hours
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
Daily "Good ON" time
|
9.2 Hours
STANDARD_DEVIATION 3.3 • n=99 Participants
|
8.5 Hours
STANDARD_DEVIATION 3.3 • n=107 Participants
|
8.9 Hours
STANDARD_DEVIATION 3.2 • n=206 Participants
|
|
Daily time with troublesome dyskinesia
|
1.2 Hours
STANDARD_DEVIATION 2.8 • n=99 Participants
|
2.5 Hours
STANDARD_DEVIATION 3.7 • n=107 Participants
|
1.9 Hours
STANDARD_DEVIATION 3.3 • n=206 Participants
|
|
UPDRS Part III (motor) score
|
37.4 Score
STANDARD_DEVIATION 14.5 • n=99 Participants
|
37.3 Score
STANDARD_DEVIATION 13.3 • n=107 Participants
|
37.3 Score
STANDARD_DEVIATION 13.7 • n=206 Participants
|
|
PD medications
Levodopa
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
PD medications
Dopamine agonists
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
PD medications
Monoamine oxidase inhibitors
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
PD medications
Amantadine
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
PD medications
Entacapone
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
PD medications
Trihexyphenidyl
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Levodopa dose
|
996 mg
STANDARD_DEVIATION 552 • n=99 Participants
|
948 mg
STANDARD_DEVIATION 305 • n=107 Participants
|
972 mg
STANDARD_DEVIATION 441 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: mITT Set
Based on Parkinson's disease symptom assessment, "ON" time is when there is good response to medication and few symptoms. "OFF" time is when no there is no response to medication and significant motor symptoms. An "ON/OFF" Log was completed by a blinded rater starting before the first dose of LD/DDI and following the first dose at 30 min intervals for 8 hrs. The changes in "OFF" time as hours (normalized to 16 hrs of awake time) during the 8 hrs of data collection were estimated. Negative change from baseline for "OFF" time indicates improvement.
Outcome measures
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
Change in Daily "OFF" Time
|
-2.8 Hours
Interval -4.6 to -0.9
|
-1.3 Hours
Interval -3.1 to 0.5
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: mITT Set in Regimen 1. Regimen 2 was not optimized for morning efficacy assessment (it required the arrival of a nurse in the morning to administer oral IR LD/CD and begin the infusion).
Based on Parkinson's disease symptom assessment, "ON" time is when there is good response to medication and few symptoms. "OFF" time is when no there is no response to medication and significant motor symptoms. Subjects were asked to indicate when exactly in their opinion they had turned to full "ON" (i.e. an "ON" response comparable to the "ON" response to standard oral LD/DDI treatment). Higher percentage of subjects with full "ON" on Day 28 indicates improvement.
Outcome measures
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
The Percentage of Subjects With Full "ON" at Approximately 08:00 and Approximately 09:00, as Determined by the Subject
Baseline: Full "ON" by 8:00
|
3 Participants
|
—
|
|
The Percentage of Subjects With Full "ON" at Approximately 08:00 and Approximately 09:00, as Determined by the Subject
Baseline: Full "ON" by 9:00
|
7 Participants
|
—
|
|
The Percentage of Subjects With Full "ON" at Approximately 08:00 and Approximately 09:00, as Determined by the Subject
Day 28: Full "ON" by 8:00
|
7 Participants
|
—
|
|
The Percentage of Subjects With Full "ON" at Approximately 08:00 and Approximately 09:00, as Determined by the Subject
Day 28: Full "ON" by 9:00
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: mITT Set
Based on Parkinson's disease symptom assessment, "ON" time is when there is good response to medication and few symptoms. "OFF" time is when no there is no response to medication and significant motor symptoms. "Good ON" time means "ON" time without troublesome dyskinesia (involuntary muscle movement), defined as the sum of "ON" time without dyskinesia and "ON" time with non-troublesome dyskinesia. An "ON/OFF" Log was completed by a blinded rater starting before the first dose of LD/DDI and following the first dose at 30 min intervals for 8 hrs. Daily total scores were normalized to 16 hours of awake time. Positive change from baseline for "ON" time without dyskinesia and for "Good ON" time, and a negative change in "ON" time with moderate or severe (troublesome) dyskinesia indicates improvement.
Outcome measures
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
Change in Daily "Good ON" Time as Assessed by a Blinded Rater
|
3.7 Hours
Interval 1.9 to 5.6
|
2.8 Hours
Interval 1.0 to 4.6
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: mITT Set
The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. UPDRS part III (motor) score is calculated as the sum of the individual UPDRS items 18-31, each of which are measured on a 5-point scale (i.e., 0 is normal and 4 indicates a severe abnormality). UPDRS part III was done as a motor examination on Day 1 before the first dose of standard oral LD/DDI and at the same time on Day 28. The range of score values is from 0 to 132. Higher scores correlate with greater motor impairment.
Outcome measures
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
Change in Morning UPDRS Part III (Motor) Scores
|
-19.1 score on a scale
Interval -25.6 to -12.5
|
-10.7 score on a scale
Interval -16.8 to -4.6
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: mITT Set
The Unified Parkinson's disease rating scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS Part II (activity of daily living) score was calculated as the sum of the individual UPDRS items 5-17. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (i.e., 0 is normal and 4 indicates a severe abnormality). The range of score values is from 0 to 52. Higher scores correlate with greater impairments for daily activities.
Outcome measures
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
Change in UPDRS Part II (ADL) Scores
|
-2.9 score on a scale
Interval -5.4 to -0.5
|
-1.9 score on a scale
Interval -4.2 to 0.4
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: mITT
Global improvement was rated by the investigator or designee using Clinical Global Impression of Improvement (CGI-I). The CGI-I employs a 7-point scale with 1 being "very much improved" and 7 being "very much worse" for improvement rating.
Outcome measures
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
CGI-Improvement (CGI-I) Score as Assessed by Investigator
Day 3: Subjects with improvements
|
10 Participants
|
9 Participants
|
|
CGI-Improvement (CGI-I) Score as Assessed by Investigator
Day 28: Subjects with improvements
|
14 Participants
|
13 Participants
|
|
CGI-Improvement (CGI-I) Score as Assessed by Investigator
CGI-I score on Day 28: Very much improved
|
5 Participants
|
2 Participants
|
|
CGI-Improvement (CGI-I) Score as Assessed by Investigator
CGI-I score on Day 28: Much improved
|
6 Participants
|
7 Participants
|
|
CGI-Improvement (CGI-I) Score as Assessed by Investigator
CGI-I score on Day 28: Minimally improved
|
3 Participants
|
4 Participants
|
|
CGI-Improvement (CGI-I) Score as Assessed by Investigator
CGI-I score on Day 28: No change
|
1 Participants
|
5 Participants
|
|
CGI-Improvement (CGI-I) Score as Assessed by Investigator
CGI-I score on Day 28: Minimally worse
|
1 Participants
|
0 Participants
|
|
CGI-Improvement (CGI-I) Score as Assessed by Investigator
CGI-I score on Day 28: Much worse
|
0 Participants
|
0 Participants
|
|
CGI-Improvement (CGI-I) Score as Assessed by Investigator
CGI-I score on Day 28: Very much worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 27Population: mITT Set
The quality of night sleep was rated by the subjects using the Parkinson's Disease Sleep Scale (PDSS)-2, which includes questions addressing 15 commonly reported symptoms associated with sleep disturbance in PD. Each question is assessed from 0 (Always) to 10 (Never). The total score values range from 0 to 150. Higher scores indicate a lower quality of sleep, i.e., a reduction in the score indicates an improvement in sleep quality.
Outcome measures
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
Change in PDSS-2 Total Score
|
-4.1 score on a scale
Interval -8.0 to -0.2
|
-0.8 score on a scale
Interval -4.4 to 2.9
|
SECONDARY outcome
Timeframe: Baseline to Day 27Population: mITT Set
Subjects were requested to rate their quality of life using the Quality of Life in Parkinson's Disease (PDQ)-39, a 39-item, self-administered questionnaire with 8 discrete dimensions (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.). The PDQ-39 Summary Index is the sum of the dimension scores divided by the number of dimensions. The total score values range from 0 to 100%. Higher scores indicate a worse quality of life.
Outcome measures
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
Change in PDQ-39 Summary Index and the 8-dimension Scores
|
-7.5 score on a scale
Interval -12.9 to -2.1
|
-3.7 score on a scale
Interval -8.9 to 1.5
|
POST_HOC outcome
Timeframe: Baseline to Day 28Population: mITT Set subjects in Regimen 1 who had valid data for the analysis at baseline and Day 28. LOCF Imputation.
Determination of percentage of subjects who had a complete and 50% reduction in daily "OFF" time from baseline to Day 28 during 8 hrs observations.
Outcome measures
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 Participants
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
Percentage of Subjects Who Achieved at Least Certain Percent Reduction in Average Daily Normalized "OFF" Time
Subjects who Achieved 50% reduction in average daily normalized "OFF" time
|
12 Participants
|
—
|
|
Percentage of Subjects Who Achieved at Least Certain Percent Reduction in Average Daily Normalized "OFF" Time
Subjects who Achieved complete reduction in average daily normalized "OFF"
|
8 Participants
|
—
|
Adverse Events
ND0612 Regimen 1 - 24-hr Infusion
ND0612 Regimen 2 - 14-hr Infusion
Serious adverse events
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 participants at risk
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
n=19 participants at risk
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
Vascular disorders
Orthostatic hypotension
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
0.00%
0/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
0.00%
0/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
Infections and infestations
Subcutaneous abscess
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
0.00%
0/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
Other adverse events
| Measure |
ND0612 Regimen 1 - 24-hr Infusion
n=19 participants at risk
Randomized participants received via a pump continuous, SC, 24-hour infusion of ND0612.
|
ND0612 Regimen 2 - 14-hr Infusion
n=19 participants at risk
Randomized participants received via a pump continuous, SC, 14-hour infusion of ND0612. Infusion started at wake-up time supplemented with an oral IR LD/CD tablet.
|
|---|---|---|
|
General disorders
Infusion site nodule
|
57.9%
11/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
36.8%
7/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
General disorders
Infusion site bruising
|
21.1%
4/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
15.8%
3/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
General disorders
Infusion site erythema
|
26.3%
5/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
10.5%
2/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
General disorders
Infusion site haemorrhage
|
10.5%
2/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
15.8%
3/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
General disorders
Infusion site haematoma
|
15.8%
3/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
General disorders
Infusion site pain
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
15.8%
3/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
General disorders
Infusion site edema
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
General disorders
Infusion site pruritus
|
10.5%
2/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
0.00%
0/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
Nervous system disorders
Parkinson's disease
|
5.3%
1/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
10.5%
2/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
Nervous system disorders
Headache
|
10.5%
2/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
0.00%
0/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
10.5%
2/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
|
Vascular disorders
Orthostatic hypotension
|
10.5%
2/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
0.00%
0/19 • From Baseline to the end of treatment plus 28 days
Treatment emergent adverse events are defined as all AEs that start on or after the start of first study drug administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
- Publication restrictions are in place
Restriction type: OTHER