Study of Milnacipran for the Treatment of Fibromyalgia

December 18, 2007 updated by: Forest Laboratories

A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1200

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
      • Mobile, Alabama, United States, 36608
        • Forest Investigative Site
      • Montgomery, Alabama, United States, 36111
        • Forest Investigative Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Forest Investigative Site
    • California
      • Beverly Hills, California, United States, 90211
        • Forest Investigative Site
      • Sacramento, California, United States, 95825
        • Forest Investigative Site
      • San Diego, California, United States, 92117
        • Forest Investigative Site
      • San Diego, California, United States, 92108
        • Forest Investigative Site
      • Santa Ana, California, United States, 92705
        • Forest Investigative Site
      • Spring Valley, California, United States, 91978
        • Forest Investigative Site
      • Torrance, California, United States, 90505
        • Forest Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Forest Investigative Site
      • Colorado Springs, Colorado, United States, 80910
        • Forest Investigative Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Forest Investigative Site
      • Stamford, Connecticut, United States, 06905
        • Forest Investigative Site
      • Trumball, Connecticut, United States, 06611
        • Forest Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Forest Investigative Site
      • Deland, Florida, United States, 32720
        • Forest Investigative Site
      • Delray Beach, Florida, United States, 33484
        • Forest Investigative Site
      • Jacksonville, Florida, United States, 33216
        • Forest Investigative Site
      • Ocala, Florida, United States, 34471
        • Forest Investigative Site
      • Ormond Beach, Florida, United States, 32174
        • Forest Investigative Site
      • Palm Harbor, Florida, United States, 34684
        • Forest Investigative Site
      • Pembroke Pines, Florida, United States, 33029
        • Forest Investigative Site
      • Port Orange, Florida, United States, 32127
        • Forest Investigative Site
      • Tamarac, Florida, United States, 33321
        • Forest Investigative Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Forest Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Forest Investigative Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Forest Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Forest Investigative Site
      • Libertyville, Illinois, United States, 60048
        • Forest Investigative Site
      • Peoria, Illinois, United States, 61614
        • Forest Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Forest Investigative Site
      • Lafayette, Indiana, United States, 47904
        • Forest Investigative Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Forest Investigative Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Forest Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Forest Investigative Site
      • Columbia, Maryland, United States, 21045
        • Forest Investigative Site
      • Frederick, Maryland, United States, 21702
        • Forest Investigative Site
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • Forest Investigative Site
      • North Dartmouth, Massachusetts, United States, 02747
        • Forest Investigative Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Forest Investigative Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Forest Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Forest Investigative Site
    • Montana
      • Missoula, Montana, United States, 59802
        • Forest Investigative Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Forest Investigative Site
      • Clementon, New Jersey, United States, 08021
        • Forest Investigative Site
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Forest Investigative Site
    • New York
      • East Syracuse, New York, United States, 13057
        • Forest Investigative Site
      • Great Neck, New York, United States, 11021
        • Forest Investigative Site
      • Rochester, New York, United States, 14618
        • Forest Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Forest Investigative Site
      • Fayetteville, North Carolina, United States, 28304
        • Forest Investigative Site
      • Hickory, North Carolina, United States, 28601
        • Forest Investigative Site
      • Raleigh, North Carolina, United States, 27612
        • Forest Investigative Site
      • Raleigh, North Carolina, United States, 27609
        • Forest Investigative Site
      • Winston-Salem, North Carolina, United States, 27103
        • Forest Investigative Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Forest Investigative Site
    • Ohio
      • Marion, Ohio, United States, 43302
        • Forest Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Forest Investigative Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Forest Investigative Site
      • Eugene, Oregon, United States, 97404
        • Forest Investigative Site
      • Medford, Oregon, United States, 97504
        • Forest Investigative Site
      • Portland, Oregon, United States, 97205
        • Forest Investigative Site
    • Pennsylvania
      • Duncanville, Pennsylvania, United States, 16635
        • Forest Investigative Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Forest Investigative Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Forest Investigative Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Forest Investigative Site
      • Chattanooga, Tennessee, United States, 37404
        • Forest Investigative Site
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site
    • Texas
      • Austin, Texas, United States, 78705
        • Forest Investigative Site
      • San Antonio, Texas, United States, 78205
        • Forest Investigative Site
      • Sugarland, Texas, United States, 77479
        • Forest Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Forest Investigative Site
      • Virginia Beach, Virginia, United States, 23454
        • Forest Investigative Site
    • Washington
      • Bellingham, Washington, United States, 98226
        • Forest Investigative Site
      • Everett, Washington, United States, 98201
        • Forest Investigative Site
      • Seattle, Washington, United States, 98166
        • Forest Investigative Site
      • Wenatchee, Washington, United States, 98801
        • 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

Exclusion Criteria:

  • Psychiatric illness
  • Depression
  • Suicidal risk
  • Substance abuse
  • Pulmonary dysfunction
  • Renal impairment
  • Active cardiac disease
  • Liver disease
  • Autoimmune disease
  • Cancer
  • Sleep apnea
  • Inflammatory bowel disease

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Composite responder analysis based on pain and patient global status, with or without physical function.

Secondary Outcome Measures

Outcome Measure
Quality of Life
Health Assessment Questionnaire (HAQ) Disability Index
Fatigue, sleep and cognitive assessments

Collaborators and Investigators

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

Sponsor

Forest Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2004

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

December 3, 2004

First Submitted That Met QC Criteria

December 3, 2004

First Posted (Estimate)

December 6, 2004

Study Record Updates

Last Update Posted (Estimate)

December 24, 2007

Last Update Submitted That Met QC Criteria

December 18, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLN-MD-02

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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