Discontinuation Study of the Durability of Effect 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. Identifier: NCT01014585
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : September 7, 2011
Last Update Posted : September 7, 2011
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Placebo Drug: Milnacipran Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment
Study Start Date : November 2009
Actual Primary Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Placebo Comparator: 1
Placebo tablets administered orally twice daily
Drug: Placebo
Placebo tablets administered orally twice daily

Experimental: 2
Milnacipran tablets administered orally twice daily
Drug: Milnacipran
Milnacipran tablets administered orally twice daily
Other Name: Savella ®

Primary Outcome Measures :
  1. Time to Loss of Therapeutic Response (LTR) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ]
    Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment

Secondary Outcome Measures :
  1. Time to Worsening in Patient Global Impression of Change (PGIC) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ]
    Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. 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.

  2. Time to Worsening in Multidimensional Assessment of Fatigue (MAF) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ]
    Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Currently participating in Study MLN-MD-06
  • Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Exclusion Criteria:

  • Significant risk of suicide
  • History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
  • Myocardial infarction and/or stroke within the prior 12 months
  • Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)
  • Active liver disease
  • Severe renal impairment
  • Platelet and bleeding disorders
  • Female patients who are pregnant or breastfeeding

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 identifier (NCT number): NCT01014585

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United States, Alabama
Forest Investigative Site 062
Birmingham, Alabama, United States, 35205
Forest Investigative Site 065
Birmingham, Alabama, United States, 35209
United States, Arizona
Forest Investigative Site 012
Tucson, Arizona, United States, 85704
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Fresno, California, United States, 93710
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Pismo Beach, California, United States, 93449
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Sacramento, California, United States, 95825
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San Diego, California, United States, 92108
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Santa Ana, California, United States, 92705
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Vista, California, United States, 92083
United States, Connecticut
Forest Investigative Site 050
Cromwell, Connecticut, United States, 06416
Forest Investigative Site 049
Danbury, Connecticut, United States, 06810
Forest Investigative Site 055
Stamford, Connecticut, United States, 06905
United States, Florida
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Delray Beach, Florida, United States, 33484
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Ocala, Florida, United States, 34471
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Orlando, Florida, United States, 32806
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Palm Harbor, Florida, United States, 34684
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Pembroke Pines, Florida, United States, 33029
United States, Georgia
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Atlanta, Georgia, United States, 30319
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Atlanta, Georgia, United States, 30328
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Honolulu, Hawaii, United States, 96814
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Libertyville, Illinois, United States, 60048
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Peoria, Illinois, United States, 61614
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Evansville, Indiana, United States, 47713
United States, Maryland
Forest Investigative Site 064
Frederick, Maryland, United States, 21702
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N. Dartmouth, Massachusetts, United States, 02747
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Newton, Massachusetts, United States, 02462
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Springfield, Massachusetts, United States, 01103
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Worcester, Massachusetts, United States, 01610
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Kalamazoo, Michigan, United States, 49009
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Jackson, Mississippi, United States, 39202
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Forest Investigative Site 004
St. Louis, Missouri, United States, 63141
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Cherry Hill, New Jersey, United States, 08002
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Albuquerque, New Mexico, United States, 87108
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Great Neck, New York, United States, 11021
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Rochester, New York, United States, 14618
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Syracuse, New York, United States, 13210
United States, North Carolina
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Charlotte, North Carolina, United States, 28209
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Greensboro, North Carolina, United States, 27408
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Greenville, North Carolina, United States, 27834
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Salisbury, North Carolina, United States, 28144
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Forest Investigative Site 003
Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44122
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Columbus, Ohio, United States, 43212
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Eugene, Oregon, United States, 97401
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Eugene, Oregon, United States, 97404
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Medford, Oregon, United States, 97504
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Medford, Oregon, United States, 97504
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Portland, Oregon, United States, 97205
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Forest Investigative Site 051
Duncansville, Pennsylvania, United States, 16635
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Mechanicsburg, Pennsylvania, United States, 17055
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Forest Investigative Site 028
Anderson, South Carolina, United States, 29621
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Greer, South Carolina, United States, 29651
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Forest Investigative Site 006
Salt Lake City, Utah, United States, 84102
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Forest Investigative Site 015
Chesapeake, Virginia, United States, 23320
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Forest Investigative Site 047
Seattle, Washington, United States, 98104
Forest Investigative Site 036
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Forest Investigative Site 063
Racine, Wisconsin, United States, 53406
Sponsors and Collaborators
Forest Laboratories
Cypress Bioscience, Inc.
Study Director: Joel Trugman, MD Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Forest Laboratories Identifier: NCT01014585     History of Changes
Other Study ID Numbers: MLN-MD-27
First Posted: November 17, 2009    Key Record Dates
Results First Posted: September 7, 2011
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by Forest Laboratories:
Durability of Effect
Loss of Therapeutic Response
Forest Research Institute
Savella ®

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents