Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Levomilnacipran; Milnacipran; Pregabalin

Criteria

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