CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 107 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 30 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/NCT01077375
NCT01077375Phase 4Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Switch Study to Evaluate the Safety, Tolerability and Efficacy of Milnacipran in Patients With an Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

Forest Laboratories·interventional·Posted Mar 1, 2010·Updated Jan 26, 2012

In Brief

A Phase 4 clinical trial evaluating Placebo and Milnacipran for Fibromyalgia. Completed, enrolled 107 participants across 26 sites.

Detailed Summary

The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
CollaboratorsCypress Bioscience, Inc.

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2010
Enrollment StartFeb 1, 2010
Primary CompletionDec 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.3 years ago

Interventions

Placebodrug

* Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper. * Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.

Milnaciprandrug

* Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper. * Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.