Study of Milnacipran for the Treatment of Fibromyalgia - Full Text View

Sponsors and Collaborators:	Forest Laboratories Cypress Bioscience, Inc.
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00314249

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 III

MedlinePlus related topics: Antidepressants Fibromyalgia

Drug Information available for: Milnacipran Milnacipran hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Composite responder analysis based on pain, patient global status, and physical function.

Secondary Outcome Measures:

Quality of Life; Health Status Assessment; Fatigue, anxiety and cognitive assessments

Estimated Enrollment:	1000
Study Start Date:	April 2006
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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,
inflammatory bowel disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314249

Show 24 Study Locations

Sponsors and Collaborators

Forest Laboratories

Cypress Bioscience, Inc.

More Information

Study ID Numbers:	MLN-MD-03
Study First Received:	April 11, 2006
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00314249
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Fibromyalgia

Study placed in the following topic categories:

Milnacipran
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Pain
Rheumatic Diseases
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Nervous System Diseases
Physiological Effects of Drugs

Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009