Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia

Phase 4 Completed 340 enrolled Forest Laboratories Cypress Bioscience, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2009-11
Primary completion: 2010-05
Completion: —

Outcome

Met primary endpoint

registry analysis (superiority or other test); Responders: Placebo (Milnacipran Withdrawn) vs Responders: Milnacipran (Milnacipran Continued); p = 0.0004; Hazard Ratio (HR) 0.44 (95% CI 0.27 to 0.71); Log Rank NCT01014585 ↗

paper Time to LTR was shorter in patients randomized to placebo than in patients continuing milnacipran (P < 0.001). PMID 23953493 ↗

Publications

Clauw DJ, Mease PJ, Palmer RH, Trugman JM, Wang Y. Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial. Arthritis Res Ther. 2013 Aug 16;15(4):R88. doi: 10.1186/ar4268.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Milnacipran	Other / unclassified	—	Oral