Study of Milnacipran Added to Pregabalin for 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: NCT00797797
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : February 16, 2011
Last Update Posted : February 16, 2011
Information provided by:
Forest Laboratories

Brief Summary:
To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: No Treatment Added Drug: Milnacipran Added Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia
Study Start Date : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Milnacipran Added Drug: Milnacipran Added
Milnacipran 100 mg/d added
Experimental: No Treatment Added Drug: No Treatment Added
No added treatment
Other Name: Lyrica (r)

Primary Outcome Measures :
  1. Patient Global Impression of Change (PGIC) Responder Rate at End of Study [ Time Frame: End of Randomized treatment period (11 weeks) ]
    The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.

Secondary Outcome Measures :
  1. Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study [ Time Frame: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks) ]
    The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
  • tolerate at least 300 mg/day of pregabalin
  • have an incomplete response to pregabalin treatment

Exclusion Criteria:

  • suicidal risk
  • substance abuse
  • pulmonary dysfunction
  • renal impairment
  • active cardiac disease
  • liver disease
  • narrow angle glaucoma
  • autoimmune disease
  • cancer
  • inflammatory bowel disease
  • unstable endocrine disease
  • prostatic enlargement

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): NCT00797797

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United States, Alabama
Forest Investigative Site
Birmingham, Alabama, United States, 35205
United States, Arizona
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Mesa, Arizona, United States, 85210
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Peoria, Arizona, United States, 85381
United States, Arkansas
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Hot Springs, Arkansas, United States, 71913
United States, California
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Anaheim, California, United States, 92801
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Sacramento, California, United States, 95821
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Sacramento, California, United States, 95825
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Torrance, California, United States, 90505
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Walnut Creek, California, United States, 94598
United States, Colorado
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Denver, Colorado, United States, 80239
United States, Connecticut
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Cromwell, Connecticut, United States, 06416
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Danbury, Connecticut, United States, 06810
United States, Florida
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Clearwater, Florida, United States, 33765
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Daytona Beach, Florida, United States, 32117
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Delray Beach, Florida, United States, 33484
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Fort Myers, Florida, United States, 33912
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Jacksonville, Florida, United States, 32216
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Miami, Florida, United States, 33169
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Ocala, Florida, United States, 34471
Forest Investigative Site Orl2
Orlando, Florida, United States, 32806
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Orlando, Florida, United States, 32806
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Ormond Beach, Florida, United States, 32174
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Pembroke Pines, Florida, United States, 33024
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Pembroke Pines, Florida, United States, 33029
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Pismo Beach, Florida, United States, 93449
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St. Petersburg, Florida, United States, 33709
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Tampa, Florida, United States, 33614
United States, Georgia
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Atlanta, Georgia, United States, 30328
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Honolulu, Hawaii, United States, 96814
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Couer D'Alene, Idaho, United States, 83814
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Evansville, Indiana, United States, 47713
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Indianapolis, Indiana, United States, 46254
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Indianapolis, Indiana, United States, 46260
United States, Maryland
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Baltimore, Maryland, United States, 21208
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No. Dartmouth, Massachusetts, United States, 02747
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Worcester, Massachusetts, United States, 01610
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Jackson, Mississippi, United States, 39202
United States, Missouri
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St. Louis, Missouri, United States, 63141
United States, Nebraska
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Omaha, Nebraska, United States, 68134
United States, New Mexico
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Albuquerque, New Mexico, United States, 87108
United States, New York
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Syracuse, New York, United States, 13210
United States, Ohio
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44122
United States, Oregon
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Eugene, Oregon, United States, 97404
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Medford, Oregon, United States, 97504
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Portland, Oregon, United States, 97210
United States, South Carolina
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Greer, South Carolina, United States, 29651
United States, Tennessee
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Memphis, Tennessee, United States, 38119
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77104
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Lake Jackson, Texas, United States, 77566
United States, Utah
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Salt Lake City, Utah, United States, 84102
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Salt Lake City, Utah, United States, 84106
United States, Vermont
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Woodstock, Vermont, United States, 05091
United States, Washington
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Bellevue, Washington, United States, 98004
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Bellingham, Washington, United States, 98226
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Seattle, Washington, United States, 98104
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Seattle, Washington, United States, 98104
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Spokane, Washington, United States, 99204
United States, Wisconsin
Forest Investigative Site
Racine, Wisconsin, United States, 53406
Sponsors and Collaborators
Forest Laboratories
Study Director: Patricia D'Astoli Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Responsible Party: James Perhach, Executive Director, Clinical Development, Forest Research Institute Inc (A Subsidiary of Forest Laboratories Inc) Identifier: NCT00797797     History of Changes
Other Study ID Numbers: MLN-MD-15
First Posted: November 25, 2008    Key Record Dates
Results First Posted: February 16, 2011
Last Update Posted: February 16, 2011
Last Verified: January 2011

Keywords provided by Forest Laboratories:
Forest Research Institute

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents