Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

January 20, 2011 updated by: Forest Laboratories

A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia

To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

364

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Forest Investigative Site
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Forest Investigative Site
      • Peoria, Arizona, United States, 85381
        • Forest Investigative Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Forest Investigative Site
    • California
      • Anaheim, California, United States, 92801
        • Forest Investigative Site
      • Sacramento, California, United States, 95821
        • Forest Investigative Site
      • Sacramento, California, United States, 95825
        • Forest Investigative Site
      • Torrance, California, United States, 90505
        • Forest Investigative Site
      • Walnut Creek, California, United States, 94598
        • Forest Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80239
        • Forest Investigative Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Forest Investigative Site
      • Danbury, Connecticut, United States, 06810
        • Forest Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Forest Investigative Site
      • Daytona Beach, Florida, United States, 32117
        • Forest Investigative Site
      • Delray Beach, Florida, United States, 33484
        • Forest Investigative Site
      • Fort Myers, Florida, United States, 33912
        • Forest Investigative Site
      • Jacksonville, Florida, United States, 32216
        • Forest Investigative Site
      • Miami, Florida, United States, 33169
        • Forest Investigative Site
      • Ocala, Florida, United States, 34471
        • Forest Investigative Site
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site Orl2
      • Ormond Beach, Florida, United States, 32174
        • Forest Investigative Site
      • Pembroke Pines, Florida, United States, 33024
        • Forest Investigative Site PP1
      • Pembroke Pines, Florida, United States, 33029
        • Forest Investigative Site PP2
      • Pismo Beach, Florida, United States, 93449
        • Forest Investigative Site
      • St. Petersburg, Florida, United States, 33709
        • Forest Investigative Site
      • Tampa, Florida, United States, 33614
        • Forest Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Forest Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Forest Investigative Site
    • Idaho
      • Couer D'Alene, Idaho, United States, 83814
        • Forest Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Forest Investigative Site
      • Indianapolis, Indiana, United States, 46254
        • Forest Investigative Site
      • Indianapolis, Indiana, United States, 46260
        • Forest Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Forest Investigative Site
    • Massachusetts
      • No. Dartmouth, Massachusetts, United States, 02747
        • Forest Investigative Site
      • Worcester, Massachusetts, United States, 01610
        • Forest Investigative Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Forest Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Forest Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Forest Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Forest Investigative Site
    • New York
      • Syracuse, New York, United States, 13210
        • Forest Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Forest Investigative Site
      • Cleveland, Ohio, United States, 44122
        • Forest Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Forest Investigative Site
      • Medford, Oregon, United States, 97504
        • Forest Investigative Site
      • Portland, Oregon, United States, 97210
        • Forest Investigative Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Forest Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site
    • Texas
      • Houston, Texas, United States, 77074
        • Forest Investigative Site
      • Houston, Texas, United States, 77104
        • Forest Investigative Site
      • Lake Jackson, Texas, United States, 77566
        • Forest Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Forest Investigative Site
      • Salt Lake City, Utah, United States, 84106
        • Forest Investigative Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Forest Investigative Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Forest Investigative Site
      • Bellingham, Washington, United States, 98226
        • Forest Investigative Site
      • Seattle, Washington, United States, 98104
        • Forest Investigative Site SEA1
      • Seattle, Washington, United States, 98104
        • Forest Investigative Site SEA2
      • Spokane, Washington, United States, 99204
        • Forest Investigative Site
    • Wisconsin
      • Racine, Wisconsin, United States, 53406
        • Forest Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
  • tolerate at least 300 mg/day of pregabalin
  • have an incomplete response to pregabalin treatment

Exclusion Criteria:

  • suicidal risk
  • substance abuse
  • pulmonary dysfunction
  • renal impairment
  • active cardiac disease
  • liver disease
  • narrow angle glaucoma
  • autoimmune disease
  • cancer
  • inflammatory bowel disease
  • unstable endocrine disease
  • prostatic enlargement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Milnacipran Added
Drug: Milnacipran Added
Milnacipran 100 mg/d added
Experimental: No Treatment Added
Drug: No Treatment Added
No added treatment
Other Names:
  • Lyrica (r)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Change (PGIC) Responder Rate at End of Study
Time Frame: End of Randomized treatment period (11 weeks)
The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.
End of Randomized treatment period (11 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study
Time Frame: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)
The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).
Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Patricia D'Astoli, Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

February 16, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLN-MD-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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