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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia|
- Composite responder analysis based on pain and patient global status, with or without physical function.
- Quality of Life
- Health Assessment Questionnaire (HAQ) Disability Index
- Fatigue, sleep and cognitive assessments
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||December 2006|
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