Conditions: Fibromyalgia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 61
Healthy volunteers: no

Brief summary:
The primary objective of this study is to assess the efficacy and safety of an extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment of fibromyalgia.

The objective of the open-label phase is to assess the safety profile and effect of Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.

Detailed description:

Arms:
arm 1: 0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening arm 2: Placebo tablets, once daily in the evening

Interventions: intervention 1: pramipexole ER intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: