Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00797797
First received: November 24, 2008
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Fibromyalgia
Drug: No Treatment Added
Drug: Milnacipran Added
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Patient Global Impression of Change (PGIC) Responder Rate at End of Study [ Time Frame: End of Randomized treatment period (11 weeks) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 364
Study Start Date: November 2008
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797797

  Hide Study Locations
Locations
United States, Alabama
Forest Investigative Site
Birmingham, Alabama, United States, 35205
United States, Arizona
Forest Investigative Site
Mesa, Arizona, United States, 85210
Forest Investigative Site
Peoria, Arizona, United States, 85381
United States, Arkansas
Forest Investigative Site
Hot Springs, Arkansas, United States, 71913
United States, California
Forest Investigative Site
Anaheim, California, United States, 92801
Forest Investigative Site
Sacramento, California, United States, 95825
Forest Investigative Site
Sacramento, California, United States, 95821
Forest Investigative Site
Torrance, California, United States, 90505
Forest Investigative Site
Walnut Creek, California, United States, 94598
United States, Colorado
Forest Investigative Site
Denver, Colorado, United States, 80239
United States, Connecticut
Forest Investigative Site
Cromwell, Connecticut, United States, 06416
Forest Investigative Site
Danbury, Connecticut, United States, 06810
United States, Florida
Forest Investigative Site
Clearwater, Florida, United States, 33765
Forest Investigative Site
Daytona Beach, Florida, United States, 32117
Forest Investigative Site
Delray Beach, Florida, United States, 33484
Forest Investigative Site
Fort Myers, Florida, United States, 33912
Forest Investigative Site
Jacksonville, Florida, United States, 32216
Forest Investigative Site
Miami, Florida, United States, 33169
Forest Investigative Site
Ocala, Florida, United States, 34471
Forest Investigative Site Orl2
Orlando, Florida, United States, 32806
Forest Investigative Site
Orlando, Florida, United States, 32806
Forest Investigative Site
Ormond Beach, Florida, United States, 32174
Forest Investigative Site PP1
Pembroke Pines, Florida, United States, 33024
Forest Investigative Site PP2
Pembroke Pines, Florida, United States, 33029
Forest Investigative Site
Pismo Beach, Florida, United States, 93449
Forest Investigative Site
St. Petersburg, Florida, United States, 33709
Forest Investigative Site
Tampa, Florida, United States, 33614
United States, Georgia
Forest Investigative Site
Atlanta, Georgia, United States, 30328
United States, Hawaii
Forest Investigative Site
Honolulu, Hawaii, United States, 96814
United States, Idaho
Forest Investigative Site
Couer D'Alene, Idaho, United States, 83814
United States, Indiana
Forest Investigative Site
Evansville, Indiana, United States, 47713
Forest Investigative Site
Indianapolis, Indiana, United States, 46260
Forest Investigative Site
Indianapolis, Indiana, United States, 46254
United States, Maryland
Forest Investigative Site
Baltimore, Maryland, United States, 21208
United States, Massachusetts
Forest Investigative Site
No. Dartmouth, Massachusetts, United States, 02747
Forest Investigative Site
Worcester, Massachusetts, United States, 01610
United States, Mississippi
Forest Investigative Site
Jackson, Mississippi, United States, 39202
United States, Missouri
Forest Investigative Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Forest Investigative Site
Omaha, Nebraska, United States, 68134
United States, New Mexico
Forest Investigative Site
Albuquerque, New Mexico, United States, 87108
United States, New York
Forest Investigative Site
Syracuse, New York, United States, 13210
United States, Ohio
Forest Investigative Site
Cincinnati, Ohio, United States, 45219
Forest Investigative Site
Cleveland, Ohio, United States, 44122
United States, Oregon
Forest Investigative Site
Eugene, Oregon, United States, 97404
Forest Investigative Site
Medford, Oregon, United States, 97504
Forest Investigative Site
Portland, Oregon, United States, 97210
United States, South Carolina
Forest Investigative Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Forest Investigative Site
Memphis, Tennessee, United States, 38119
United States, Texas
Forest Investigative Site
Houston, Texas, United States, 77104
Forest Investigative Site
Houston, Texas, United States, 77074
Forest Investigative Site
Lake Jackson, Texas, United States, 77566
United States, Utah
Forest Investigative Site
Salt Lake City, Utah, United States, 84102
Forest Investigative Site
Salt Lake City, Utah, United States, 84106
United States, Vermont
Forest Investigative Site
Woodstock, Vermont, United States, 05091
United States, Washington
Forest Investigative Site
Bellevue, Washington, United States, 98004
Forest Investigative Site
Bellingham, Washington, United States, 98226
Forest Investigative Site SEA1
Seattle, Washington, United States, 98104
Forest Investigative Site SEA2
Seattle, Washington, United States, 98104
Forest Investigative Site
Spokane, Washington, United States, 99204
United States, Wisconsin
Forest Investigative Site
Racine, Wisconsin, United States, 53406
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Patricia D'Astoli Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
  More Information

No publications provided

Responsible Party: James Perhach, Executive Director, Clinical Development, Forest Research Institute Inc (A Subsidiary of Forest Laboratories Inc)
ClinicalTrials.gov Identifier: NCT00797797     History of Changes
Other Study ID Numbers: MLN-MD-15
Study First Received: November 24, 2008
Results First Received: November 18, 2010
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
fibromyalgia
milnacipran
pregabalin
treatment
Forest Research Institute

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Pregabalin
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on April 23, 2014