NCT01077375

Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Two weeks Duloxetine 60 mg Open-Label Period * Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine) * One week Double-Blind Down-Taper Period

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Placebo	* 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.
DRUG	Milnacipran	* 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.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2010-03-01
• Last updated: 2012-01-26
• Results posted: 2012-01-26

Locations

26 sites across 1 country: United States