Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia Syndrome Rotigotine Neupro
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 230
Healthy volunteers: no

Brief summary:
This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain, sleep, general activity, mood, and quality of life, and the use of rescue medication to treat pain will be assessed.

Detailed description:
The overall post-Baseline duration of treatment was 13 weeks. The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week De-escalation Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo during the Maintenance Phase. During the 4-week Titration Phase, subjects assigned to rotigotine were titrated at weekly intervals of 2 mg/24 hrs until they reached 4 mg/24 hrs or 8 mg/24 hrs. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase and were maintained at their randomized dose (rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo). No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Arms:
arm 1: Placebo arm 2: 4 mg/24 hrs arm 3: 8 mg/24 hrs

Interventions: intervention 1: Rotigotine intervention 2: Rotigotine intervention 3: Placebo
Intervention descriptions: intervention 1: Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch) intervention 2: Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches) intervention 3: Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.

Protocol document: