Study of Milnacipran for the Treatment of Fibromyalgia
Phase 3
Completed
- Conditions
- Fibromyalgia
- Registration Number
- NCT00098124
- Lead Sponsor
- Forest Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Composite responder analysis based on pain and patient global status, with or without physical function.
- Secondary Outcome Measures
Name Time Method Quality of Life Health Assessment Questionnaire (HAQ) Disability Index Fatigue, sleep and cognitive assessments
Trial Locations
- Locations (1)
Forest Investigative Site
🇺🇸Racine, Wisconsin, United States