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

Study Overview
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Brief Summary
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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.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Milnacipran
* Drug: Placebo
* Drug: Placebo
* Drug: Milnacipran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks. | Drug: Milnacipran<br>* Twice daily oral administration of Milnacipran for 5 weeks.<br>Drug: Placebo<br>* Twice daily oral administration of placebo for 5 weeks.<br>|
| Experimental: 2<br>Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks. | Drug: Placebo<br>* Twice daily oral administration of placebo for 5 weeks.<br>Drug: Milnacipran<br>* Twice daily oral administration of Milnacipran for 5 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Medium Pressure Pain Threshold From Baseline to End of Treatment. | 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. | Week 0, 5, 7 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment. | 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 | Weeks 0, 5, 7 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, milnacipran, Forest Laboratories