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

Sponsor:	Forest Laboratories
Collaborator:	Cypress Bioscience, Inc.
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00314249

Purpose

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

Condition	Intervention	Phase
Fibromyalgia	Drug: Placebo Drug: Milnacipran 100mg	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Milnacipran hydrochloride Milnacipran

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Composite Syndrome Responder Status [ Time Frame: At the end of the three-month stable dose treatment phase ] [ Designated as safety issue: No ]
Composite Pain Responder Status [ Time Frame: At the end of three-month stable dose treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase [ Time Frame: Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12) ] [ Designated as safety issue: No ]
Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. [ Time Frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase ] [ Designated as safety issue: No ]
Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. [ Time Frame: Baseline through end of week 12 (Visit TX12) ] [ Designated as safety issue: No ]
Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12 [ Time Frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase ] [ Designated as safety issue: No ]

Enrollment:	1025
Study Start Date:	April 2006
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo, oral administration, twice daily for 12 weeks	Drug: Placebo Placebo, oral administration, twice daily for 12 weeks
Experimental: Milnacipran Milnacipran 100mg/day (50mg BID [twice a day])	Drug: Milnacipran 100mg Milnacipran 100mg per day (50mg BID [twice a day])

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

No publications provided by Forest Laboratories

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

Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Sep;62(9):2745-56.

Responsible Party:	Robert Palmer, MD, Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00314249 History of Changes
Other Study ID Numbers:	MLN-MD-03
Study First Received:	April 11, 2006
Results First Received:	June 30, 2009
Last Updated:	January 14, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

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 February 09, 2012