At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 340 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in 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.
A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment
In Brief
A Phase 4 clinical trial evaluating Placebo and Milnacipran for Fibromyalgia. Completed, enrolled 340 participants across 58 sites.
Detailed Summary
The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
CollaboratorsCypress Bioscience, Inc.
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedNov 2009
Primary CompletionMay 2010
TodayJul 2026
First PostedNov 17, 2009
Enrollment StartNov 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.6 years ago
Interventions
Placebodrug
Placebo tablets administered orally twice daily
Milnaciprandrug
Milnacipran tablets administered orally twice daily