Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014585
• Other study ID #: MLN-MD-27
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2009
• Last updated: September 2, 2011
• Start date: November 2009

Study information

• Verified date: September 2011
• 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 is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently participating in Study MLN-MD-06

• Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Exclusion Criteria:

• Significant risk of suicide

• History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder

• Myocardial infarction and/or stroke within the prior 12 months

• Mean systolic blood pressure > 180 mm Hg or mean diastolic blood pressure > 110 mm Hg at Screening (Visit 1)

• Active liver disease

• Severe renal impairment

• Platelet and bleeding disorders

• Female patients who are pregnant or breastfeeding

Study Design

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Placebo
Placebo tablets administered orally twice daily
• Milnacipran
Milnacipran tablets administered orally twice daily

Locations

Country	Name	City	State
United States	Forest Investigative Site 040	Albuquerque	New Mexico
United States	Forest Investigative Site 028	Anderson	South Carolina
United States	Forest Investigative Site 009	Atlanta	Georgia
United States	Forest Investigative Site 066	Atlanta	Georgia
United States	Forest Investigative Site 062	Birmingham	Alabama
United States	Forest Investigative Site 065	Birmingham	Alabama
United States	Forest Investigative Site 054	Charlotte	North Carolina
United States	Forest Investigative Site 033	Cherry Hill	New Jersey
United States	Forest Investigative Site 015	Chesapeake	Virginia
United States	Forest Investigative Site 003	Cincinnati	Ohio
United States	Forest Investigative Site 005	Cleveland	Ohio
United States	Forest Investigative Site 059	Columbus	Ohio
United States	Forest Investigative Site 050	Cromwell	Connecticut
United States	Forest Investigative Site 049	Danbury	Connecticut
United States	Forest Investigative Site 011	Delray Beach	Florida
United States	Forest Investigative Site 051	Duncansville	Pennsylvania
United States	Forest Investigative Site 010	Eugene	Oregon
United States	Forest Investigative Site 044	Eugene	Oregon
United States	Forest Investigative Site 031	Evansville	Indiana
United States	Forest Investigative Site 064	Frederick	Maryland
United States	Forest Investigative Site 007	Fresno	California
United States	Forest Investigative Site 035	Great Neck	New York
United States	Forest Investigative Site 018	Greensboro	North Carolina
United States	Forest Investigative Site 002	Greenville	North Carolina
United States	Forest Investigative Site 021	Greer	South Carolina
United States	Forest Investigative Site 026	Honolulu	Hawaii
United States	Forest Investigative Site 020	Jackson	Mississippi
United States	Forest Investigative Site 061	Kalamazoo	Michigan
United States	Forest Investigative Site 056	Libertyville	Illinois
United States	Forest Investigative Site 046	Mechanicsburg	Pennsylvania
United States	Forest Investigative Site 001	Medford	Oregon
United States	Forest Investigative Site 052	Medford	Oregon
United States	Forest Investigative Site 048	N. Dartmouth	Massachusetts
United States	Forest Investigative Site 030	Newton	Massachusetts
United States	Forest Investigative Site 013	Ocala	Florida
United States	Forest Investigative Site 016	Orlando	Florida
United States	Forest Investigative Site 043	Palm Harbor	Florida
United States	Forest Investigative Site 060	Pembroke Pines	Florida
United States	Forest Investigative Site 038	Peoria	Illinois
United States	Forest Investigative Site 032	Pismo Beach	California
United States	Forest Investigative Site 041	Portland	Oregon
United States	Forest Investigative Site 063	Racine	Wisconsin
United States	Forest Investigative Site 014	Rochester	New York
United States	Forest Investigative Site 025	Sacramento	California
United States	Forest Investigative Site 024	Salisbury	North Carolina
United States	Forest Investigative Site 006	Salt Lake City	Utah
United States	Forest Investigative Site 019	San Diego	California
United States	Forest Investigative Site 057	Santa Ana	California
United States	Forest Investigative Site 047	Seattle	Washington
United States	Forest Investigative Site 017	Springfield	Massachusetts
United States	Forest Investigative Site 004	St. Louis	Missouri
United States	Forest Investigative Site 055	Stamford	Connecticut
United States	Forest Investigative Site 027	Syracuse	New York
United States	Forest Investigative Site 012	Tucson	Arizona
United States	Forest Investigative Site 039	Vista	California
United States	Forest Investigative Site 036	Wenatchee	Washington
United States	Forest Investigative Site 042	Winston-Salem	North Carolina
United States	Forest Investigative Site 008	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	Time to Loss of Therapeutic Response (LTR)	Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment	From baseline Visit 3 (week 5) to Visit 7 (week 17)	No
Secondary	Time to Worsening in Patient Global Impression of Change (PGIC)	Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. The wording of the assessment is as follows: "Since the start of the study, overall my fibromyalgia is:" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.	From baseline Visit 3 (week 5) to Visit 7 (week 17)	No
Secondary	Time to Worsening in Multidimensional Assessment of Fatigue (MAF)	Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).	From baseline Visit 3 (week 5) to Visit 7 (week 17)	No