Conditions: Parkinson Disease
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 511
Healthy volunteers: no

Brief summary:
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).

Detailed description:

Arms:
arm 1: Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily arm 2: Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.

Interventions: intervention 1: Placebo intervention 2: Pramipexole
Intervention descriptions: intervention 1: Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase. intervention 2: ER 0.375-4,5 mg

Protocol document: