Fibromyalgia Clinical Trial
NCT number | NCT00793520 |
Other study ID # | MLN-MD-16 |
Secondary ID | |
Status | Terminated |
Phase | Phase 3 |
First received | November 17, 2008 |
Last updated | June 1, 2010 |
Start date | November 2008 |
Verified date | June 2010 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Forest Investigative Site | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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