Study of Milnacipran for the Treatment of Fibromyalgia
A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia
1 other identifier
interventional
1,200
1 country
80
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2004
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 3, 2004
CompletedFirst Posted
Study publicly available on registry
December 6, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedDecember 24, 2007
December 1, 2007
December 3, 2004
December 18, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite responder analysis based on pain and patient global status, with or without physical function.
Secondary Outcomes (3)
Quality of Life
Health Assessment Questionnaire (HAQ) Disability Index
Fatigue, sleep and cognitive assessments
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
You may not qualify if:
- Psychiatric illness
- Depression
- Suicidal risk
- Substance abuse
- Pulmonary dysfunction
- Renal impairment
- Active cardiac disease
- Liver disease
- Autoimmune disease
- Cancer
- Sleep apnea
- Inflammatory bowel disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
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
Related Publications (1)
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.
PMID: 19108787DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 3, 2004
First Posted
December 6, 2004
Study Start
November 1, 2004
Study Completion
December 1, 2006
Last Updated
December 24, 2007
Record last verified: 2007-12