CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 230 enrolled
Drug / intervention
Rotigotine +2 moredrug
Likely dose
Rotigotine 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00464737
NCT00464737Phase 2Completed
CompareCT.gov

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

UCB Pharma·interventional·Posted Apr 24, 2007·Updated Jun 22, 2015

In Brief

A Phase 2 clinical trial evaluating Rotigotine and Placebo for Fibromyalgia Syndrome. Completed, enrolled 230 participants across 35 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 24, 2007
Enrollment StartMar 1, 2007
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.2 years ago

Interventions

Rotigotinedrug

Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch)

Rotigotinedrug

Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches)

Placeboother

Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.