NCT00464737

The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.

A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 2 Different Doses of Rotigotine in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia Syndrome

Interventions

Type	Name	Description
DRUG	Rotigotine	Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch)
DRUG	Rotigotine	Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches)
OTHER	Placebo	Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-04-24
• Last updated: 2015-06-22
• Results posted: 2010-01-05

Locations

35 sites across 1 country: United States