Conditions: Parkinson Disease
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 391
Healthy volunteers: no

Brief summary:
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).

Detailed description:

Arms:
arm 1: Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily arm 2: Patients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase

Interventions: intervention 1: Pramipexole intervention 2: Placebo
Intervention descriptions: intervention 1: Pramipexole ER 0.375 -4.5 mg intervention 2: Placebo tablets identical to Pramipexole ER tablets

Protocol document: