Back to resultsEffect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Milnacipran
Placebo
Placebo
Milnacipran
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, milnacipran, Forest Laboratories
Eligibility Criteria
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
Sites / Locations
- Forest Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00793520
Brief Title
Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, milnacipran, Forest Laboratories
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
Arm Title
2
Arm Type
Experimental
Arm Description
Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Intervention Description
Twice daily oral administration of Milnacipran for 5 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Twice daily oral administration of placebo for 5 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Twice daily oral administration of placebo for 5 weeks.
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Intervention Description
Twice daily oral administration of Milnacipran for 5 weeks.
Primary Outcome Measure Information:
Title
Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.
Description
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.
Time Frame
Week 0, 5, 7 and 12
Secondary Outcome Measure Information:
Title
Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.
Description
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
Time Frame
Weeks 0, 5, 7 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Spera
Organizational Affiliation
Forest Research Institute, a subsidiary of Forest Laboratories Inc
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia
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