drugset / Trial / NCT00098124

Study of Milnacipran for the Treatment of Fibromyalgia

NCT00098124 ↗

Phase 3 Completed 1200 enrolled Forest Laboratories
RandomizedParallel-groupDouble-blindTreatment

Summary

Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.

Timeline

Start
2004-11
Primary completion
—
Completion
2006-12

Outcome

Met primary endpoint

paper Compared with placebo, significantly greater proportions of milnacipran-treated patients were FM composite responders (100 mg/d: P = 0.01; 200 mg/d: P = 0.02) and FM pain composite responders (100 mg/d: P = 0.03; 200 mg/d: P = 0.004). PMID 19108787 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Milnacipran Other / unclassified 100 mg —
Subject Milnacipran Other / unclassified 200 mg —

Indications