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:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Milnacipran Levomilnacipran Milnacipran hydrochloride

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 (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098124

Show 80 Study Locations

Sponsors and Collaborators

Forest Laboratories

More Information

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

Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther. 2008 Nov;30(11):1988-2004. doi: 10.1016/j.clinthera.2008.11.009. Erratum in: Clin Ther. 2009 Feb;31(2):446. Clin Ther. 2009 Jul;31(7):1617.


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	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

ClinicalTrials.gov processed this record on September 28, 2016

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