Status:
COMPLETED
A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Forest Laboratories
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief Summary
Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue. Researchers want to find out if "a drug" called milnacipran can help people with fibromyalgia. milnacipran (Savel...
Detailed Description
The objective of this study is to evaluate the effect of milnacipran on pain processing in patients with fibromyalgia and to assess the correlation between this effect and neural activation patterns d...
Eligibility Criteria
Inclusion
- You may be eligible to take part in this study if the following are true:
- You are between the age of 18 and 70 years
- If you are female
- If you are right handed
- You have a diagnosis of fibromyalgia for at least 3 months, as defined by the American College of Rheumatology 1990 Criteria
- You are willing to stop taking certain medicines that you may be taking on a regular basis. The researchers will discuss these medications with you in detail
Exclusion
- You may not be eligible take part in this study if any of the following are true for you:
- You have problems with your heart or cardiovascular system
- You have problems with your liver or kidneys
- You have an autoimmune disease, or a whole-body infection like HIV or hepatitis
- You have cancer
- You are pregnant or breastfeeding
- You abuse drugs or alcohol
- You have suicidal thoughts or wishes
- You have taken milnacipran or another study drug within the last 30 days
- You have a medical problem not listed here that would make it unsafe for you to take part in the study
- The research team feels that you will be unable to complete all phases of the study
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01173055
Start Date
June 1 2010
End Date
June 1 2012
Last Update
November 8 2017
Active Locations (1)
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1
University of Michigan, Chronic Pain and Fatigue Research Center
Ann Arbor, Michigan, United States, 48106