A Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With Levodopa
Overview
- Phase
- Phase 3
- Intervention
- pramipexole extended release tablet
- Conditions
- Parkinson Disease
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 475
- Locations
- 20
- Primary Endpoint
- Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
pramipexole Extended release
subjects will receive 0.375mg once a day to 4.5mg once a day depending on investigator's judgement
Intervention: pramipexole extended release tablet
pramipexole Immediate release
subjects will receive 0.125mg three times a day to 1.0mg three times a day depending on investigator's judgement
Intervention: pramipexole immediate release tablet
Outcomes
Primary Outcomes
Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
Time Frame: Baseline and week 18
UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
Secondary Outcomes
- Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18(Baseline and week 18)
- Responder in Percentage Off-time During Waking Hours at Week 18(Baseline and week 18)
- Change From Baseline in Percentage On-time Without Dyskinesia at Week 18(Baseline and week 18)
- Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18(Baseline and week 18)
- Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18(Baseline and week 18)
- Change From Baseline in Percentage Off-time During Waking Hours at Week 18(Baseline and week 18)
- Change From Baseline in Duration of Off-time During Waking Hours at Week 18(Baseline and week 18)
- Change From Baseline in Duration of On-time Without Dyskinesia at Week 18(Baseline and week 18)
- Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18(Baseline and week 18)
- Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18(Baseline and week 18)
- Patient Global Impressions of Improvement (PGI-I) Responder at Week 18(18 weeks)
- Responder in UPDRS Parts II+III Score at Week 18(Baseline and week 18)
- Levodopa (L-Dopa) Dose Change During the Study(18 weeks)
- Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18(Baseline and week 18)
- Clinical Global Impression of Improvement (CGI-I) Responder at Week 18(18 weeks)
- Change From Baseline in UPDRS II Score Separately at Week 18(Baseline and week 18)
- Change From Baseline in UPDRS III Score Separately at Week 18(Baseline and week 18)
- Levodopa (L-Dopa) Introduction During the Study(18 weeks)