Study of Milnacipran for the Treatment of Fibromyalgia

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: milnacipran hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00098124

MLN-MD-02

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind