Study of Milnacipran for the Treatment of Fibromyalgia

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Placebo; Drug: Milnacipran 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00314249

MLN-MD-03

Details and patient eligibility

About

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

Enrollment: 1,025 patients

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,
• inflammatory bowel disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,025 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo, oral administration, twice daily for 12 weeks

Treatment:

Drug: Placebo

Milnacipran

Experimental group

Description:

Milnacipran 100mg/day (50mg BID \[twice a day\])

Treatment:

Drug: Milnacipran 100mg