Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 17, 2008
CompletedFirst Posted
Study publicly available on registry
November 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedResults Posted
Study results publicly available
July 1, 2010
CompletedJuly 1, 2010
June 1, 2010
5 months
November 17, 2008
April 15, 2010
June 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.
Weeks 0, 5, 7 and 12
Study Arms (2)
1
EXPERIMENTALTwice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
2
EXPERIMENTALTwice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) criteria
- Visual analog pain score between 40 and 90 mm
- Right-hand dominance
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Forest Investigative Site
Ann Arbor, Michigan, 48106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects enrolled. Technical problems with MRI equipment resulted in early study termination. No analysis was performed.
Results Point of Contact
- Title
- Allan Spera
- Organization
- Forest Research Institute
Study Officials
- STUDY DIRECTOR
Allan Spera
Forest Research Institute, a subsidiary of Forest Laboratories Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2008
First Posted
November 19, 2008
Study Start
November 1, 2008
Primary Completion
April 1, 2009
Last Updated
July 1, 2010
Results First Posted
July 1, 2010
Record last verified: 2010-06