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:	Treatment, Randomized, Double Blind (Subject, Investigator), 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.

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: Placebo Comparator Placebo, oral administration, twice daily for 12 weeks	Drug: Placebo Placebo, oral administration, twice daily for 12 weeks
Milnacipran: Experimental 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

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

Keywords provided by Forest Laboratories:

Fibromyalgia

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Fibromyalgia
Myofascial Pain Syndromes
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Rheumatic Diseases

Serotonin Uptake Inhibitors
Pharmacologic Actions
Milnacipran
Serotonin Agents
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010