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

This study has been terminated.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00793520
First received: November 17, 2008
Last updated: June 1, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Intervention Phase
Fibromyalgia
 Drug: Milnacipran
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change in Medium Pressure Pain Threshold From Baseline to End of Treatment. [ Time Frame: Week 0, 5, 7 and 12 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Weeks 0, 5, 7 and 12 ] [ Designated as safety issue: No ]
    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


Enrollment: 2
Study Start Date: November 2008
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793520

Locations
United States, Michigan
Forest Investigative Site
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Allan Spera Forest Research Institute, a subsidiary of Forest Laboratories Inc
  More Information

No publications provided

Responsible Party: James Perhach, PhD, Executive Director, Clinical Development, Neurology, Forest Research Insititute
ClinicalTrials.gov Identifier: NCT00793520     History of Changes
Other Study ID Numbers: MLN-MD-16
Study First Received: November 17, 2008
Results First Received: April 15, 2010
Last Updated: June 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
fibromyalgia
milnacipran
Forest Laboratories

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on June 18, 2013