Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: No Treatment Added; Drug: Milnacipran Added

Study type: Interventional

Funder types: Industry

Identifiers

NCT00797797

MLN-MD-15

Details and patient eligibility

About

To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Enrollment: 364 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
• tolerate at least 300 mg/day of pregabalin
• have an incomplete response to pregabalin treatment

Exclusion criteria

• suicidal risk
• substance abuse
• pulmonary dysfunction
• renal impairment
• active cardiac disease
• liver disease
• narrow angle glaucoma
• autoimmune disease
• cancer
• inflammatory bowel disease
• unstable endocrine disease
• prostatic enlargement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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364 participants in 2 patient groups

Milnacipran Added

Experimental group

Treatment:

Drug: Milnacipran Added

No Treatment Added

Experimental group

Treatment:

Drug: No Treatment Added