CClinicalTrials.gg
CompletedNCT00098124Updated Dec 24, 2007

Study of Milnacipran for the Treatment of Fibromyalgia

A Phase 3 interventional study of milnacipran hydrochloride in Fibromyalgia, sponsored by Forest Laboratories. Completed at 80 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-12-24.

Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Fibromyalgia

Keywords

  • NSRI
  • milnacipran
  • fibromyalgia
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 1,200 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
1,200 participants

Interventions

  • Drugmilnacipran hydrochloride
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Quality of Life

  2. Health Assessment Questionnaire (HAQ) Disability Index

  3. Fatigue, sleep and cognitive assessments

07

Study locations

80 sites
  • Forest Investigative Site
    Birmingham, Alabama 35205, United States
  • Forest Investigative Site
    Mobile, Alabama 36608, United States
  • Forest Investigative Site
    Montgomery, Alabama 36111, United States
  • Forest Investigative Site
    Peoria, Arizona 85381, United States
  • Forest Investigative Site
    Beverly Hills, California 90211, United States
  • Forest Investigative Site
    Sacramento, California 95825, United States
  • Forest Investigative Site
    San Diego, California 92108, United States
  • Forest Investigative Site
    San Diego, California 92117, United States
  • Forest Investigative Site
    Santa Ana, California 92705, United States
  • Forest Investigative Site
    Spring Valley, California 91978, United States
  • Forest Investigative Site
    Torrance, California 90505, United States
  • Forest Investigative Site
    Colorado Springs, Colorado 80909, United States
  • Forest Investigative Site
    Colorado Springs, Colorado 80910, United States
  • Forest Investigative Site
    Danbury, Connecticut 06810, United States
  • Forest Investigative Site
    Stamford, Connecticut 06905, United States
  • Forest Investigative Site
    Trumball, Connecticut 06611, United States
  • Forest Investigative Site
    Clearwater, Florida 33761, United States
  • Forest Investigative Site
    Deland, Florida 32720, United States
  • Forest Investigative Site
    Delray Beach, Florida 33484, United States
  • Forest Investigative Site
    Jacksonville, Florida 33216, United States
  • Forest Investigative Site
    Ocala, Florida 34471, United States
  • Forest Investigative Site
    Ormond Beach, Florida 32174, United States
  • Forest Investigative Site
    Palm Harbor, Florida 34684, United States
  • Forest Investigative Site
    Pembroke Pines, Florida 33029, United States
  • Forest Investigative Site
    Port Orange, Florida 32127, United States
  • Forest Investigative Site
    Tamarac, Florida 33321, United States
  • Forest Investigative Site
    Decatur, Georgia 30033, United States
  • Forest Investigative Site
    Honolulu, Hawaii 96814, United States
  • Forest Investigative Site
    Meridian, Idaho 83642, United States
  • Forest Investigative Site
    Chicago, Illinois 60612, United States
  • Forest Investigative Site
    Libertyville, Illinois 60048, United States
  • Forest Investigative Site
    Peoria, Illinois 61614, United States
  • Forest Investigative Site
    Evansville, Indiana 47713, United States
  • Forest Investigative Site
    Lafayette, Indiana 47904, United States
  • Forest Investigative Site
    Wichita, Kansas 67207, United States
  • Forest Investigative Site
    Lexington, Kentucky 40509, United States
  • Forest Investigative Site
    Baltimore, Maryland 21237, United States
  • Forest Investigative Site
    Columbia, Maryland 21045, United States
  • Forest Investigative Site
    Frederick, Maryland 21702, United States
  • Forest Investigative Site
    Newton, Massachusetts 02462, United States
  • Forest Investigative Site
    North Dartmouth, Massachusetts 02747, United States
  • Forest Investigative Site
    Kalamazoo, Michigan 49009, United States
  • Forest Investigative Site
    Flowood, Mississippi 39232, United States
  • Forest Investigative Site
    St. Louis, Missouri 63141, United States
  • Forest Investigative Site
    Missoula, Montana 59802, United States
  • Forest Investigative Site
    Cherry Hill, New Jersey 08002, United States
  • Forest Investigative Site
    Clementon, New Jersey 08021, United States
  • Forest Investigative Site
    Santa Fe, New Mexico 87505, United States
  • Forest Investigative Site
    East Syracuse, New York 13057, United States
  • Forest Investigative Site
    Great Neck, New York 11021, United States
  • Forest Investigative Site
    Rochester, New York 14618, United States
  • Forest Investigative Site
    Charlotte, North Carolina 28209, United States
  • Forest Investigative Site
    Fayetteville, North Carolina 28304, United States
  • Forest Investigative Site
    Hickory, North Carolina 28601, United States
  • Forest Investigative Site
    Raleigh, North Carolina 27609, United States
  • Forest Investigative Site
    Raleigh, North Carolina 27612, United States
  • Forest Investigative Site
    Winston-Salem, North Carolina 27103, United States
  • Forest Investigative Site
    Bismarck, North Dakota 58501, United States
  • Forest Investigative Site
    Marion, Ohio 43302, United States
  • Forest Investigative Site
    Oklahoma City, Oklahoma 73112, United States
  • Forest Investigative Site
    Bend, Oregon 97701, United States
  • Forest Investigative Site
    Eugene, Oregon 97404, United States
  • Forest Investigative Site
    Medford, Oregon 97504, United States
  • Forest Investigative Site
    Portland, Oregon 97205, United States
  • Forest Investigative Site
    Duncanville, Pennsylvania 16635, United States
  • Forest Investigative Site
    Warwick, Rhode Island 02886, United States
  • Forest Investigative Site
    Orangeburg, South Carolina 29118, United States
  • Forest Investigative Site
    Bristol, Tennessee 37620, United States
  • Forest Investigative Site
    Chattanooga, Tennessee 37404, United States
  • Forest Investigative Site
    Memphis, Tennessee 38119, United States
  • Forest Investigative Site
    Austin, Texas 78705, United States
  • Forest Investigative Site
    San Antonio, Texas 78205, United States
  • Forest Investigative Site
    Sugarland, Texas 77479, United States
  • Forest Investigative Site
    Richmond, Virginia 23294, United States
  • Forest Investigative Site
    Virginia Beach, Virginia 23454, United States
  • Forest Investigative Site
    Bellingham, Washington 98226, United States
  • Forest Investigative Site
    Everett, Washington 98201, United States
  • Forest Investigative Site
    Seattle, Washington 98166, United States
  • Forest Investigative Site
    Wenatchee, Washington 98801, United States
  • Forest Investigative Site
    Racine, Wisconsin 53406, United States
08

References and documents

Publications

  • Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther. 2008 Nov;30(11):1988-2004. doi: 10.1016/j.clinthera.2008.11.009. Erratum In: Clin Ther. 2009 Feb;31(2):446. Clin Ther. 2009 Jul;31(7):1617. PubMed 19108787 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00098124
Lead sponsor
Forest Laboratories
First posted
Dec 6, 2004
Start date
Nov 2004
Completion
Dec 2006
Last update
Dec 24, 2007
View the source record on ClinicalTrials.gov ↗

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