At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 119 enrolled
Drug / intervention
Pregabalin +1 moredrug
Likely dose
Pregabalin 450 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.
Effects Of Pregabalin On Sleep Maintenance In Subjects With Fibromyalgia Syndrome And Sleep Maintenance Disturbance: A Randomized Placebo-Controlled 2-Way Crossover Polysomnography Study
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Apr 20, 2009·Updated Jan 25, 2021
In Brief
A Phase 3 clinical trial evaluating Pregabalin and Placebo for Fibromyalgia and Sleep Disorders. Completed, enrolled 119 participants across 50 sites in 3 countries.
Detailed Summary
The purpose of the study is to demonstrate the effect of Lyrica on Wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia, Sleep Disorders
CountriesCanada, Germany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartJun 2009
Primary CompletionJun 2010
TodayJul 2026
First PostedApr 20, 2009
Enrollment StartJun 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.2 years ago
Interventions
Pregabalindrug
Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks titrated to 300-450 mg/day
Placebodrug
Capsule, flexible dosing double-blind. Treatment duration is approximately 4 weeks