drugset / Trial / NCT00560508

A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period

NCT00560508

Phase 2/3 Completed 112 enrolled Boehringer Ingelheim
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).

Timeline

Start
2007-11
Primary completion
2009-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Pramipexole Unknown 0.25 mg
Subject Pramipexole Unknown 0.375 mg
Subject Pramipexole Unknown 4.5 mg

Indications