Trial Outcomes & Findings for Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment (NCT NCT02365870)
NCT ID: NCT02365870
Last Updated: 2020-03-31
Results Overview
The main outcome measure for this study was change in anxiety symptom severity over the course of the study. Anxiety severity was measured using the Hamilton Anxiety Rating Scale (HARS).The HARS is a 14-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 56, with scores greater than 17 indicating mild severity, scores between 18 and 24 indicating mild to moderate severity and scores greater than 25 indicating moderate to severe severity.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
Baseline, weeks 2, 4 and 8
Results posted on
2020-03-31
Participant Flow
Participant milestones
| Measure |
Rotigotine
rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily
|
Placebo
placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
placebo: Participants will receive a placebo transdermal patch to be worn daily
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment
Baseline characteristics by cohort
| Measure |
Rotigotine
n=1 Participants
rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily
|
Placebo
n=3 Participants
placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
placebo: Participants will receive a placebo transdermal patch to be worn daily
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 0 • n=99 Participants
|
68.3 years
STANDARD_DEVIATION 6.4 • n=107 Participants
|
62.75 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Participants with Depression at baseline
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, weeks 2, 4 and 8The main outcome measure for this study was change in anxiety symptom severity over the course of the study. Anxiety severity was measured using the Hamilton Anxiety Rating Scale (HARS).The HARS is a 14-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 56, with scores greater than 17 indicating mild severity, scores between 18 and 24 indicating mild to moderate severity and scores greater than 25 indicating moderate to severe severity.
Outcome measures
| Measure |
Rotigotine
n=1 Participants
rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily
|
Placebo
n=3 Participants
placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
placebo: Participants will receive a placebo transdermal patch to be worn daily
|
|---|---|---|
|
Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale
Baseline
|
23 score on a scale
Standard Deviation 0
|
20.7 score on a scale
Standard Deviation 5.1
|
|
Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale
Week 2
|
20 score on a scale
Standard Deviation 0
|
13.7 score on a scale
Standard Deviation 6.4
|
|
Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale
Week 4
|
5 score on a scale
Standard Deviation 0
|
18.3 score on a scale
Standard Deviation 13.6
|
|
Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale
Week 8
|
9 score on a scale
Standard Deviation 0
|
14.7 score on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline, weeks 2, 4 and 8The main outcome measure for this study was change in depression symptom severity over the course of the study. Depression severity was measured using the Hamilton Depression Rating Scale (HAMD). The HAMD is a 17-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 68, with scores greater than 7 indicating mild depressive symptoms.
Outcome measures
| Measure |
Rotigotine
n=1 Participants
rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily
|
Placebo
n=3 Participants
placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
placebo: Participants will receive a placebo transdermal patch to be worn daily
|
|---|---|---|
|
Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale
Week 8
|
5 score on a scale
Standard Deviation 0
|
4.3 score on a scale
Standard Deviation 5.1
|
|
Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale
Baseline
|
10 score on a scale
Standard Deviation 0
|
8 score on a scale
Standard Deviation 2
|
|
Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale
Week 2
|
10 score on a scale
Standard Deviation 0
|
5.3 score on a scale
Standard Deviation 1.5
|
|
Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale
Week 4
|
4 score on a scale
Standard Deviation 0
|
7.3 score on a scale
Standard Deviation 7.1
|
Adverse Events
Rotigotine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rotigotine
n=1 participants at risk
rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily
|
Placebo
n=3 participants at risk
placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
placebo: Participants will receive a placebo transdermal patch to be worn daily
|
|---|---|---|
|
General disorders
Excessive Somnolence
|
0.00%
0/1 • Adverse event data were collected during the course of the study. This spanned from baseline through the tapering period for the drug (up to 42 days after the final study visit).
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected during the course of the study. This spanned from baseline through the tapering period for the drug (up to 42 days after the final study visit).
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/1 • Adverse event data were collected during the course of the study. This spanned from baseline through the tapering period for the drug (up to 42 days after the final study visit).
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected during the course of the study. This spanned from baseline through the tapering period for the drug (up to 42 days after the final study visit).
|
|
Cardiac disorders
Edema
|
0.00%
0/1 • Adverse event data were collected during the course of the study. This spanned from baseline through the tapering period for the drug (up to 42 days after the final study visit).
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected during the course of the study. This spanned from baseline through the tapering period for the drug (up to 42 days after the final study visit).
|
Additional Information
Dr. Gregory Pontone
Johns Hopkins University School of Medicine
Phone: (410) 502 - 0477
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place