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Study of Milnacipran for the Treatment of Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00314249
Recruitment Status : Completed
First Posted : April 13, 2006
Results First Posted : November 1, 2009
Last Update Posted : January 20, 2010
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by:
Forest Laboratories

Study Description
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Brief Summary:
The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Placebo Drug: Milnacipran 100mg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1025 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Study Start Date : April 2006
Actual Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo, oral administration, twice daily for 12 weeks
 Drug: Placebo
Placebo, oral administration, twice daily for 12 weeks
Experimental: Milnacipran
Milnacipran 100mg/day (50mg BID [twice a day])
 Drug: Milnacipran 100mg
Milnacipran 100mg per day (50mg BID [twice a day])


Outcome Measures
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Primary Outcome Measures :
  1. Composite Syndrome Responder Status [ Time Frame: At the end of the three-month stable dose treatment phase ]
    Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of "very much improved" and "much improved;" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)

  2. Composite Pain Responder Status [ Time Frame: At the end of three-month stable dose treatment phase ]
    Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved."


Secondary Outcome Measures :
  1. Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase [ Time Frame: Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12) ]

    Time-weighted average (area under the curve [AUC]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time.

    PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain).


  2. Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. [ Time Frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase ]

    Time-weighted average (area under the curve [AUC]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time.

    PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: "Since the start of the study, overall my fibromyalgia is:" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse.


  3. Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. [ Time Frame: Baseline through end of week 12 (Visit TX12) ]

    Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue.

    MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1="yes, that is true" and 5="no, that is not true."


  4. Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12 [ Time Frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase ]

    Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains & 2 component summaries (mental and physical); assessing quality of life, health & functional status.

    SF-36 PCS: weighted summary of physical function using all 8 domains.

    Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status.

    SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time.



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

Exclusion Criteria:

  • psychiatric illness,
  • depression,
  • suicidal risk,
  • substance abuse,
  • pulmonary dysfunction,
  • renal impairment,
  • active cardiac disease,
  • liver disease,
  • autoimmune disease,
  • cancer,
  • inflammatory bowel disease
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): NCT00314249


Locations
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United States, Alabama
Forest Investigative Site
Tuscaloosa, Alabama, United States, 35406
United States, California
Forest Investigative Site
Fresno, California, United States, 93710
Forest Investigative Site
Pismo Beach, California, United States, 93449
Forest Investigative Site
Vista, California, United States, 92083
United States, Florida
Forest Investigative Site
St. Petersburg, Florida, United States, 33702
Forest Investigative Site
St. Petersburg, Florida, United States, 33709
Forest Investigative Site
Stuart, Florida, United States, 34996
United States, Georgia
Forest Investigative Site
Atlanta, Georgia, United States, 30328
United States, Massachusetts
Forest Investigative Site
Springfield, Massachusetts, United States, 01107
Forest Investigative Site
Worcester, Massachusetts, United States, 01610
United States, Nebraska
Forest Investigative Site
Omaha, Nebraska, United States, 68134
United States, New Jersey
Forest Investigative Site
Haddon Heights, New Jersey, United States, 08035
United States, New York
Forest Investigative Site
Johnson City, New York, United States, 13790
Forest Investigative Site
Syracuse, New York, United States, 13210
United States, North Carolina
Forest Investigative Site
Greensboro, North Carolina, United States, 27408
United States, Ohio
Forest Investigative Site
Cleveland, Ohio, United States, 44122
Forest Investigative Site
Columbus, Ohio, United States, 43212
Forest Investigative Site
Toledo, Ohio, United States, 43623
United States, Oregon
Forest Investigative Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Forest Investigative Site
Mechanicsburg, Pennsylvania, United States, 17055
United States, South Carolina
Forest Investigative Site
Anderson, South Carolina, United States, 29621
Forest Investigative Site
Greer, South Carolina, United States, 29651
United States, Texas
Forest Investigative Site
Richardson, Texas, United States, 75080
United States, Virginia
Forest Investigative Site
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
Forest Laboratories
Cypress Bioscience, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Robert Palmer, MD, Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00314249    
Other Study ID Numbers: MLN-MD-03
First Posted: April 13, 2006    Key Record Dates
Results First Posted: November 1, 2009
Last Update Posted: January 20, 2010
Last Verified: January 2010
Keywords provided by Forest Laboratories:
Fibromyalgia
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