A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients
Summary
Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks
Timeline
- Start
- 2006-11
- Primary completion
- 2008-09
- Completion
- —
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo vs Mirapex (Pramipexole 0.5 mg Tid); p <0.0001; Mean Difference (Final Values) -4.4 (95% CI -6.53 to -2.26); ANCOVA NCT00402233 ↗
registry analysis (superiority or other test); Placebo vs Mirapex (Pramipexole 0.5 mg Bid); p <0.0001; Mean Difference (Final Values) -4.41 (95% CI -6.54 to -2.28); ANCOVA NCT00402233 ↗
registry analysis (superiority or other test); Placebo vs Mirapex (Pramipexole 0.75 mg Bid); p <0.0001; Mean Difference (Final Values) -4.72 (95% CI -6.91 to -2.52); ANCOVA NCT00402233 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pramipexole | Unknown | 0.5 mg | — |
| Subject | Pramipexole | Unknown | 0.75 mg | — |