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Study of Milnacipran for the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00098124
First received: December 3, 2004
Last updated: December 18, 2007
Last verified: December 2007
History of Changes
  Purpose

Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.


Condition Intervention Phase
Fibromyalgia
 Drug: milnacipran hydrochloride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Composite responder analysis based on pain and patient global status, with or without physical function.

Secondary Outcome Measures:
  • Quality of Life
  • Health Assessment Questionnaire (HAQ) Disability Index
  • Fatigue, sleep and cognitive assessments

Estimated Enrollment: 1200
Study Start Date: November 2004
Estimated Study Completion Date: December 2006
  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

Exclusion Criteria:

  • Psychiatric illness
  • Depression
  • Suicidal risk
  • Substance abuse
  • Pulmonary dysfunction
  • Renal impairment
  • Active cardiac disease
  • Liver disease
  • Autoimmune disease
  • Cancer
  • Sleep apnea
  • Inflammatory bowel disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098124

  Show 80 Study Locations
Sponsors and Collaborators
Forest Laboratories
  More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00098124     History of Changes
Other Study ID Numbers: MLN-MD-02
Study First Received: December 3, 2004
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
NSRI
milnacipran
fibromyalgia

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 May 19, 2013