Study of Milnacipran for the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314249
• Other study ID #: MLN-MD-03
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2006
• Last updated: January 14, 2010
• Start date: April 2006

Study information

• Verified date: January 2010
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1025
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Placebo
Placebo, oral administration, twice daily for 12 weeks
• Milnacipran 100mg
Milnacipran 100mg per day (50mg BID [twice a day])

Locations

Country	Name	City	State
United States	Forest Investigative Site	Anderson	South Carolina
United States	Forest Investigative Site	Atlanta	Georgia
United States	Forest Investigative Site	Cleveland	Ohio
United States	Forest Investigative Site	Columbus	Ohio
United States	Forest Investigative Site	Eugene	Oregon
United States	Forest Investigative Site	Fresno	California
United States	Forest Investigative Site	Greensboro	North Carolina
United States	Forest Investigative Site	Greer	South Carolina
United States	Forest Investigative Site	Haddon Heights	New Jersey
United States	Forest Investigative Site	Johnson City	New York
United States	Forest Investigative Site	Mechanicsburg	Pennsylvania
United States	Forest Investigative Site	Omaha	Nebraska
United States	Forest Investigative Site	Pismo Beach	California
United States	Forest Investigative Site	Richardson	Texas
United States	Forest Investigative Site	Springfield	Massachusetts
United States	Forest Investigative Site	St. Petersburg	Florida
United States	Forest Investigative Site	St. Petersburg	Florida
United States	Forest Investigative Site	Stuart	Florida
United States	Forest Investigative Site	Syracuse	New York
United States	Forest Investigative Site	Toledo	Ohio
United States	Forest Investigative Site	Tuscaloosa	Alabama
United States	Forest Investigative Site	Virginia Beach	Virginia
United States	Forest Investigative Site	Vista	California
United States	Forest Investigative Site	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Cypress Bioscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Syndrome Responder Status		At the end of the three-month stable dose treatment phase	No
Primary	Composite Pain Responder Status		At the end of three-month stable dose treatment phase	No
Secondary	Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase		Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)	No
Secondary	Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.		Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase	No
Secondary	Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.		Baseline through end of week 12 (Visit TX12)	No
Secondary	Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12		Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase	No