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

Forest Laboratories

Status and phase: Terminated; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Placebo; Drug: Milnacipran

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793520

MLN-MD-16

Details and patient eligibility

About

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.

Enrollment: 2 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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2 participants in 2 patient groups

1

Experimental group

Description:

Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.

Treatment:

Drug: Milnacipran

Drug: Milnacipran

Drug: Placebo

Drug: Placebo

2

Experimental group

Description:

Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.

Treatment:

Drug: Milnacipran

Drug: Milnacipran

Drug: Placebo

Drug: Placebo