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

NCT01077375 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2012-01-26

Study results available

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.

Conditions

Fibromyalgia

Interventions

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.

Sponsors & Collaborators

Cypress Bioscience, Inc.
collaborator INDUSTRY
Forest Laboratories
lead INDUSTRY

Principal Investigators

Allan Spera · Forest Research Institute Inc., A Subsidiary of Forest Laboratories

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: QUADRUPLE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Max Age: 70 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2010-02-28
Primary Completion: 2010-12-31
Completion: 2011-01-31

Countries

United States

Study Locations

More Related Trials

Entities

Drugs

Placebo