Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria

• Visual analog pain score between 40 and 90 mm

• Right-hand dominance

Exclusion Criteria:

• Suicidal risk

• Substance Abuse

• Pulmonary dysfunction

• Renal impairment

• Active cardiac disease

• Autoimmune disease

• Uncontrolled narrow-angle glaucoma

• Active liver disease

• Cancer

• Active peptic ulcer disease or a history of inflammatory bowel disease or celiac sprue

• Unstable endocrine disease

• Prostatic enlargement