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

Phase 3

Terminated

• Conditions: Fibromyalgia
• Interventions: Drug: Milnacipran; Drug: Placebo

• Registration Number: NCT00793520
• Lead Sponsor: Forest Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Primary Completion: 2009-04
• Results First Submitted: 2010-04-15
• Status Verified: 2010-06
• Results First Submitted QC: 2010-06-01
• Last Update Submitted: 2010-06-01
• Results First Posted: 2010-07-01
• Last Update Posted: 2010-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Placebo	Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
2	Placebo	Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
1	Milnacipran	Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
2	Milnacipran	Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.	Week 0, 5, 7 and 12	Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.

Secondary Outcome Measures

Name	Time	Method
Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.	Weeks 0, 5, 7 and 12	DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 \& 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient's right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC

Trial Locations

Locations (1)

Forest Investigative Site; 🇺🇸 Ann Arbor, Michigan, United States