Trial Outcomes & Findings for Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD) (NCT NCT00321854)
NCT ID: NCT00321854
Last Updated: 2014-05-16
Results Overview
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
COMPLETED
PHASE4
535 participants
Baseline and Month 15
2014-05-16
Participant Flow
Participant milestones
| Measure |
Early Pramipexole
Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
|
Delayed Pramipexole
Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
261
|
274
|
|
Overall Study
COMPLETED
|
198
|
192
|
|
Overall Study
NOT COMPLETED
|
63
|
82
|
Reasons for withdrawal
| Measure |
Early Pramipexole
Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
|
Delayed Pramipexole
Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
41
|
43
|
|
Overall Study
Lack of Efficacy
|
9
|
14
|
|
Overall Study
Protocol Violation
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
17
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
Baseline characteristics by cohort
| Measure |
Early Pramipexole
n=261 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=274 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
Total
n=535 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
62.9 Years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
62.5 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 15Population: The Phase 2 Full Analysis Set (FAS2) was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
|
0.3 Units on a scale
Standard Error 0.7
|
0.7 Units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
|
0.6 Units on a scale
Standard Error 0.7
|
0.5 Units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
|
-0.5 Units on a scale
Standard Error 0.6
|
4.3 Units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
|
-1.8 Units on a scale
Standard Error 0.6
|
2.6 Units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=198 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
|
-2.9 Units on a scale
Standard Error 0.5
|
-0.1 Units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
|
0.6 Units on a scale
Standard Error 0.7
|
0.7 Units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
|
0.8 Units on a scale
Standard Error 0.7
|
0.6 Units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
|
-0.3 Units on a scale
Standard Error 0.6
|
4.2 Units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
|
-1.5 Units on a scale
Standard Error 0.6
|
2.5 Units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=198 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
|
-2.8 Units on a scale
Standard Error 0.5
|
0.0 Units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
|
0.1 Units on a scale
Standard Error 0.5
|
0.3 Units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
|
0.2 Units on a scale
Standard Error 0.5
|
-0.1 Units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
|
-0.6 Units on a scale
Standard Error 0.5
|
2.7 Units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
|
-1.6 Units on a scale
Standard Error 0.4
|
1.3 Units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=198 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
|
-2.1 Units on a scale
Standard Error 0.4
|
-0.3 Units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
|
0.5 Units on a scale
Standard Error 0.2
|
0.4 Units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
|
0.6 Units on a scale
Standard Error 0.2
|
0.6 Units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
|
0.4 Units on a scale
Standard Error 0.2
|
1.5 Units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
|
0.1 Units on a scale
Standard Error 0.2
|
1.2 Units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=198 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
|
-0.7 Units on a scale
Standard Error 0.2
|
0.3 Units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
|
-0.3 Units on a scale
Standard Error 0.1
|
0 Units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
|
-0.2 Units on a scale
Standard Error 0.1
|
-0.1 Units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
|
-0.2 Units on a scale
Standard Error 0.1
|
0.1 Units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
|
-0.3 Units on a scale
Standard Error 0.1
|
0.1 Units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=198 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
|
-0.2 Units on a scale
Standard Error 0.1
|
-0.1 Units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 27 patients from the FAS2 were excluded due to insufficient CGI-I data.
The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.
Outcome measures
| Measure |
Early Pramipexole
n=200 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=184 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
|
18 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 4 patients from the FAS2 were excluded due to insufficient CGI-I data.
The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (\>1 category improvement), 'Unchanged' or 'Worsened' (\>1 category worsening).
Outcome measures
| Measure |
Early Pramipexole
n=209 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=198 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
Improved
|
4 Participants
|
3 Participants
|
|
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
Essentially unchanged
|
200 Participants
|
191 Participants
|
|
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
Worsened
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient BDI data.
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=197 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
|
-1 Units on a scale
Standard Error 0.3
|
-0.5 Units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=199 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
|
-1.1 Units on a scale
Standard Error 0.3
|
0.3 Units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=199 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
|
-1.2 Units on a scale
Standard Error 0.3
|
0.2 Units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=198 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
|
-1 Units on a scale
Standard Error 0.3
|
-0.3 Units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial.
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
|
-0.4 Units on a scale
Inter-Quartile Range -0.4 • Interval -3.2 to 3.8
|
0.3 Units on a scale
Inter-Quartile Range 0.3 • Interval -3.6 to 4.4
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Outcome measures
| Measure |
Early Pramipexole
n=209 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=199 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
|
-0.5 Units on a scale
Inter-Quartile Range -0.5 • Interval -3.6 to 2.0
|
1.4 Units on a scale
Inter-Quartile Range 1.4 • Interval -2.2 to 5.0
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=200 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
|
0 Units on a scale
Inter-Quartile Range 0 • Interval -0.026 to 0.092
|
0 Units on a scale
Inter-Quartile Range 0 • Interval -0.079 to 0.078
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Outcome measures
| Measure |
Early Pramipexole
n=209 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=199 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
|
0 Units on a scale
Inter-Quartile Range 0 • Interval -0.026 to 0.092
|
0 Units on a scale
Inter-Quartile Range 0 • Interval -0.14 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.
The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
Outcome measures
| Measure |
Early Pramipexole
n=210 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=199 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
|
0 Units on a scale
Inter-Quartile Range 0 • Interval -8.0 to 7.0
|
0 Units on a scale
Inter-Quartile Range 0 • Interval -10.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 5 patients from the FAS2 were excluded due to insufficient efficacy data.
The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
Outcome measures
| Measure |
Early Pramipexole
n=208 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=198 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
|
0 Units on a scale
Inter-Quartile Range 0 • Interval -5.5 to 5.0
|
-0.5 Units on a scale
Inter-Quartile Range -0.5 • Interval -10.0 to 5.0
|
SECONDARY outcome
Timeframe: Month 1Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Outcome measures
| Measure |
Early Pramipexole
n=146 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=133 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
No risk of gambling
|
146 Participants
|
133 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
Risk of gambling
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Outcome measures
| Measure |
Early Pramipexole
n=146 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=134 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
Risk of gambling
|
0 Participants
|
0 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
No risk of gambling
|
146 Participants
|
134 Participants
|
SECONDARY outcome
Timeframe: Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Outcome measures
| Measure |
Early Pramipexole
n=146 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=134 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
No risk of gambling
|
146 Participants
|
134 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
Risk of gambling
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Outcome measures
| Measure |
Early Pramipexole
n=143 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=128 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
No risk of gambling
|
143 Participants
|
128 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
Risk of gambling
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Outcome measures
| Measure |
Early Pramipexole
n=145 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=132 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
No risk of gambling
|
145 Participants
|
132 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
Risk of gambling
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 1Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Outcome measures
| Measure |
Early Pramipexole
n=146 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=133 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
No compulsive sexual behaviour
|
146 Participants
|
133 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
Compulsive sexual behaviour
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Outcome measures
| Measure |
Early Pramipexole
n=146 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=134 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
No compulsive sexual behaviour
|
146 Participants
|
134 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
Compulsive sexual behaviour
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Outcome measures
| Measure |
Early Pramipexole
n=146 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=134 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
No compulsive sexual behaviour
|
146 Participants
|
134 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
Compulsive sexual behaviour
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Outcome measures
| Measure |
Early Pramipexole
n=143 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=128 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
No compulsive sexual behaviour
|
143 Participants
|
126 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
Compulsive sexual behaviour
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Outcome measures
| Measure |
Early Pramipexole
n=145 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=132 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
No compulsive sexual behaviour
|
145 Participants
|
131 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
Compulsive sexual behaviour
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Month 1Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Outcome measures
| Measure |
Early Pramipexole
n=146 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=133 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
No compulsive buying
|
145 Participants
|
133 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
Compulsive buying
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Outcome measures
| Measure |
Early Pramipexole
n=146 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=134 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
No compulsive buying
|
144 Participants
|
134 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
Compulsive buying
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 9Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Outcome measures
| Measure |
Early Pramipexole
n=146 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=134 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
No compulsive buying
|
143 Participants
|
134 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
Compulsive buying
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Outcome measures
| Measure |
Early Pramipexole
n=143 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=128 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
No compulsive buying
|
141 Participants
|
128 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
Compulsive buying
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 15Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Outcome measures
| Measure |
Early Pramipexole
n=145 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=132 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
No compulsive buying
|
143 Participants
|
132 Participants
|
|
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
Compulsive buying
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: The substudy set was made up of all randomised patients with a baseline and end of treatment assessment of striatal uptake.
The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).
Outcome measures
| Measure |
Early Pramipexole
n=62 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=61 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Percentage Change From Baseline in the Striatum Uptake at Month 15
|
-15.1 Percentage change
Standard Error 2.1
|
-14.6 Percentage change
Standard Error 2
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: Treated set: Haematocrit and mean corpuscular volume (MCV-N) was 211 for Early PPX and 209 for Delayed PPX, Haemoglobin-N was 213 for Early PPX and 212 for Delayed PPX, Sodium-N was 211 for Early PPX and 209 for Delayed PPX, Calcium and Chloride-N was 214 for Early PPX and 209 for Delayed PPX, Phosphate-N was 201 for Early and Delayed PPX
Outcome measures
| Measure |
Early Pramipexole
n=211 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=209 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Haematocrit - decrease
|
1.4 percentage of participants
|
1.0 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Haemoglobin - decrease
|
2.3 percentage of participants
|
0.9 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
MCV - increase
|
0.5 percentage of participants
|
0 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Sodium - decrease
|
1.4 percentage of participants
|
0.5 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Calcium - increase
|
0 percentage of participants
|
0.5 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Chloride - decrease
|
0.9 percentage of participants
|
0 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Phosphate - decrease
|
1.0 percentage of participants
|
0 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Phosphate - increase
|
0.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: Gamma Glutamyltranspeptidase (GGT-N) was 214 for Early PPX and 208 for Delayed PPX, Amylase-N was 214 for Early PPX and 209 for Delayed PPX
Outcome measures
| Measure |
Early Pramipexole
n=214 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=209 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
GGT - increase
|
0.5 percentage of participants
|
0 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
Amylase - increase
|
1.4 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: Glucose-N was 28 for Early PPX and 46 for Delayed PPX, Cholesterol and Triglyceride-N was 213 for Early PPX and 208 for Delayed PPX, Blood Urea Nitrogen-N was 214 for Early PPX and 209 for Delayed PPX, Creatinine-N was 200 for Early PPX and 202 for Delayed PPX, Uric Acid-N was 212 for Early PPX and 209 for Delayed PPX.
Outcome measures
| Measure |
Early Pramipexole
n=214 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=209 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Glucose - decrease
|
0 percentage of participants
|
2.2 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Glucose - increase
|
3.6 percentage of participants
|
0 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Cholesterol - increase
|
1.4 percentage of participants
|
2.9 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Blood Urea Nitrogen - increase
|
0.9 percentage of participants
|
0.5 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Creatinine - increase
|
0.5 percentage of participants
|
1.0 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Triglyceride - increase
|
1.4 percentage of participants
|
0 percentage of participants
|
|
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Uric acid - increase
|
0.5 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 15Population: Phase 1 Treated set for sinus bradycardia with N of 261 for Early PPX and 274 for Delayed PPX. Phase 2 Treated set for hypotension with N of 221 for Early PPX and 214 for Delayed PPX.
Outcome measures
| Measure |
Early Pramipexole
n=261 Participants
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=274 Participants
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Clinically Significant Abnormalities in Vital Signs
Sinus bradycardia
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Clinically Significant Abnormalities in Vital Signs
Hypotension
|
0 percentage of participants
|
0.5 percentage of participants
|
Adverse Events
Early Pramipexole
Delayed Pramipexole
Serious adverse events
| Measure |
Early Pramipexole
n=261 participants at risk
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=274 participants at risk
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.73%
2/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Infections and infestations
Bacterial infection
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Infections and infestations
Gastroenteristis
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Infections and infestations
Influenza
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.73%
2/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell carcinoma of the respiratory tract stage unspecified
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
0.77%
2/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.77%
2/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Pakinson's disease
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Pakinsonism
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Eye disorders
Macular hole
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Eye disorders
Pterygium
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Ear and labyrinth disorders
Deafness
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Vascular disorders
Peripheral arterial occulsive disease
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Gastrointestinal disorders
Small intestine obstruction
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
General disorders
Chest pain
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
General disorders
Hyperplasia
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Radial nerve injury
|
0.38%
1/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.00%
0/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
0.36%
1/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
Other adverse events
| Measure |
Early Pramipexole
n=261 participants at risk
1.5 milligrams/day pramipexole (for up to 15 months)
|
Delayed Pramipexole
n=274 participants at risk
Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.3%
19/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
8.8%
24/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
10.0%
26/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
7.7%
21/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Psychiatric disorders
Depression
|
6.9%
18/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
5.8%
16/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
5.4%
14/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
2.2%
6/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Psychiatric disorders
Abnormal dreams
|
3.1%
8/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
5.1%
14/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Somnolence
|
13.8%
36/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
7.7%
21/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
13.4%
35/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
12.0%
33/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Nervous system disorders
Headache
|
7.7%
20/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
10.2%
28/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Vascular disorders
Hypertension
|
4.2%
11/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
5.8%
16/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
23.8%
62/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
17.9%
49/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
7.3%
19/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
10.2%
28/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
10/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
8.0%
22/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
24/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
6.6%
18/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
17/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
2.2%
6/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
General disorders
Fatigue
|
13.8%
36/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
13.9%
38/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
|
General disorders
Oedema peripheral
|
9.6%
25/261 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
4.7%
13/274 • Onset date after the date of first dose up to 48 hours after last dose of study drug.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER