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Study of Milnacipran for the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00098124
First Posted: December 6, 2004
Last Update Posted: December 24, 2007
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.
Information provided by:
Forest Laboratories
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  • Sleep apnea
  • Inflammatory bowel disease
  Contacts and Locations
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): NCT00098124


  Show 80 Study Locations
Sponsors and Collaborators
Forest Laboratories
  More Information

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
First Submitted: December 3, 2004
First Posted: December 6, 2004
Last Update Posted: December 24, 2007
Last Verified: December 2007

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
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