Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients

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 .

Timeline

Start

2010-08

Primary completion

2012-01

Completion

2012-01

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Pramipexole ER vs Pramipexole IR; p <0.0001 NCT01191944 ↗

registry Mean Difference (Final Values) 0.760 (95% CI -1.047 to 2.566); ANCOVA; note: one-sided test relative to NI margin of -4 NCT01191944 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pramipexole	Unknown	0.125 mg	Oral
Subject	Pramipexole	Unknown	0.375 mg	Oral
Subject	Pramipexole	Unknown	1 mg	Oral
Subject	Pramipexole	Unknown	4.5 mg	Oral

Indications