drugset / Trial / NCT00402233

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

NCT00402233

Phase 4 Completed 312 enrolled Boehringer Ingelheim
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Pramipexole Unknown 0.5 mg
Subject Pramipexole Unknown 0.75 mg

Indications