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

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ClinicalTrials.gov Identifier: NCT00793520
Recruitment Status : Terminated
First Posted : November 19, 2008
Results First Posted : July 1, 2010
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:
Forest Laboratories

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Milnacipran Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2008
Actual Primary Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
 Drug: Milnacipran
Twice daily oral administration of Milnacipran for 5 weeks.

Drug: Placebo
Twice daily oral administration of placebo for 5 weeks.
Experimental: 2
Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
 Drug: Placebo
Twice daily oral administration of placebo for 5 weeks.

Drug: Milnacipran
Twice daily oral administration of Milnacipran for 5 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Medium Pressure Pain Threshold From Baseline to End of Treatment. [ Time Frame: Week 0, 5, 7 and 12 ]
    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 :
  1. Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment. [ Time Frame: Weeks 0, 5, 7 and 12 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793520


Locations
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United States, Michigan
Forest Investigative Site
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Allan Spera Forest Research Institute, a subsidiary of Forest Laboratories Inc
More Information
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Responsible Party: James Perhach, PhD, Executive Director, Clinical Development, Neurology, Forest Research Insititute
ClinicalTrials.gov Identifier: NCT00793520    
Other Study ID Numbers: MLN-MD-16
First Posted: November 19, 2008    Key Record Dates
Results First Posted: July 1, 2010
Last Update Posted: July 1, 2010
Last Verified: June 2010
Keywords provided by Forest Laboratories:
fibromyalgia
milnacipran
Forest Laboratories
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Levomilnacipran
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs