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

NCT01077375 | Completed Phase 4 Results

• 1 other identifier: MLN-MD-28
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 26

Brief 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

Keywords

Milnacipran; Duloxetine; Switch; Forest Research Institute

Outcome Measures

Primary Outcomes (1)

• Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)

  The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.

  Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.

Secondary Outcomes (1)

• Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score

  Change from Baseline (Week 3) to Visit 5 (Week 13)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo tablets, twice a day, oral administration

Drug: Placebo

Milnacipran

EXPERIMENTAL

Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.

Drug: Milnacipran

Interventions

Placebo DRUG

* 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.

Placebo

Milnacipran DRUG

* 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.

Also known as: Savella

Milnacipran

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of fibromyalgia
• Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)
• Duloxetine must have been prescribed for the treatment of Fibromyalgia
• Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm
• At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment.

You may not qualify if:

• Suicidal risk
• History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
• Myocardial infarction and/or stroke within the prior 6 months
• Systolic blood pressure \> 160 mm Hg or mean diastolic blood pressure \> 100 mm Hg at Screening (Visit 1)
• Substance abuse
• Pulmonary dysfunction
• Severe renal impairment
• Active cardiac disease
• Liver disease
• Uncontrolled narrow-angle glaucoma
• Autoimmune disease
• Cancer
• Inflammatory bowel disease
• Unstable endocrine disease
• Prostatic enlargement

Sponsors & Collaborators

• Forest Laboratories: lead
• Cypress Bioscience, Inc.: collaborator

Study Sites (26)

Forest Investigative Site 013

Sacramento, California, 95825, United States

Location

Forest Investigative Site 022

Cromwell, Connecticut, 06416, United States

Location

Forest Investigative Site 021

Danbury, Connecticut, 06810, United States

Location

Forest Investigative Site 007

Delray Beach, Florida, 33484, United States

Location

Forest Investigative Site 008

Ocala, Florida, 34471, United States

Location

Forest Investigative Site 009

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 016

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 012

St. Petersburg, Florida, 33709, United States

Location

Forest Investigative Site 019

Tampa, Florida, 33614, United States

Location

Forest Investigative Site 006

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 024

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 015

Evansville, Indiana, 47713, United States

Location

Forest Investigative Site 005

Worchester, Massachusetts, 01610, United States

Location

Forest Investigative Site 010

Jackson, Mississippi, 39202, United States

Location

Forest Investigative Site 025

St Louis, Missouri, 63141, United States

Location

Forest Investigative Site 018

Willingboro, New Jersey, 08046, United States

Location

Forest Investigative Site 014

Syracuse, New York, 13210, United States

Location

Forest Investigative Site 023

Charlotte, North Carolina, 28209, United States

Location

Forest Investigative Site 002

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site 003

Cleveland, Ohio, 44122, United States

Location

Forest Investigative Site 001

Medford, Oregon, 97504, United States

Location

Forest Investigative Site 020

Mechanicsburg, Pennsylvania, 17055, United States

Location

Forest Investigative Site 011

Greer, South Carolina, 29651, United States

Location

Forest Investigative Site 004

Salt Lake City, Utah, 84102, United States

Location

Forest Investigative Site 017

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 026

Racine, Wisconsin, 53406, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Allan Spera, Director, Clinical Development
• Organization: Forest Research Institute

Allan.Spera@frx.com

(201) 427-8399

Study Officials

• Allan Spera

  Forest Research Institute Inc., A Subsidiary of Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: January 26, 2012
• Results First Posted: January 26, 2012

Record last verified: 2011-12

Locations

US (26)