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

This study has been completed.
Sponsor:
Collaborator:
Cypress Bioscience, Inc.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01014585
First received: November 13, 2009
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: Placebo
Drug: Milnacipran
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Time to Loss of Therapeutic Response (LTR) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Time to Worsening in Patient Global Impression of Change (PGIC) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ] [ Designated as safety issue: No ]
    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.

  • Time to Worsening in Multidimensional Assessment of Fatigue (MAF) [ Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17) ] [ Designated as safety issue: No ]
    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).


Enrollment: 340
Study Start Date: November 2009
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo tablets administered orally twice daily
Drug: Placebo
Placebo tablets administered orally twice daily
Experimental: 2
Milnacipran tablets administered orally twice daily
Drug: Milnacipran
Milnacipran tablets administered orally twice daily
Other Name: Savella ®

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014585

  Hide Study Locations
Locations
United States, Alabama
Forest Investigative Site 065
Birmingham, Alabama, United States, 35209
Forest Investigative Site 062
Birmingham, Alabama, United States, 35205
United States, Arizona
Forest Investigative Site 012
Tucson, Arizona, United States, 85704
United States, California
Forest Investigative Site 007
Fresno, California, United States, 93710
Forest Investigative Site 032
Pismo Beach, California, United States, 93449
Forest Investigative Site 025
Sacramento, California, United States, 95825
Forest Investigative Site 019
San Diego, California, United States, 92108
Forest Investigative Site 057
Santa Ana, California, United States, 92705
Forest Investigative Site 039
Vista, California, United States, 92083
United States, Connecticut
Forest Investigative Site 050
Cromwell, Connecticut, United States, 06416
Forest Investigative Site 049
Danbury, Connecticut, United States, 06810
Forest Investigative Site 055
Stamford, Connecticut, United States, 06905
United States, Florida
Forest Investigative Site 011
Delray Beach, Florida, United States, 33484
Forest Investigative Site 013
Ocala, Florida, United States, 34471
Forest Investigative Site 016
Orlando, Florida, United States, 32806
Forest Investigative Site 043
Palm Harbor, Florida, United States, 34684
Forest Investigative Site 060
Pembroke Pines, Florida, United States, 33029
United States, Georgia
Forest Investigative Site 066
Atlanta, Georgia, United States, 30319
Forest Investigative Site 009
Atlanta, Georgia, United States, 30328
United States, Hawaii
Forest Investigative Site 026
Honolulu, Hawaii, United States, 96814
United States, Illinois
Forest Investigative Site 056
Libertyville, Illinois, United States, 60048
Forest Investigative Site 038
Peoria, Illinois, United States, 61614
United States, Indiana
Forest Investigative Site 031
Evansville, Indiana, United States, 47713
United States, Maryland
Forest Investigative Site 064
Frederick, Maryland, United States, 21702
United States, Massachusetts
Forest Investigative Site 048
N. Dartmouth, Massachusetts, United States, 02747
Forest Investigative Site 030
Newton, Massachusetts, United States, 02462
Forest Investigative Site 017
Springfield, Massachusetts, United States, 01103
Forest Investigative Site 008
Worcester, Massachusetts, United States, 01610
United States, Michigan
Forest Investigative Site 061
Kalamazoo, Michigan, United States, 49009
United States, Mississippi
Forest Investigative Site 020
Jackson, Mississippi, United States, 39202
United States, Missouri
Forest Investigative Site 004
St. Louis, Missouri, United States, 63141
United States, New Jersey
Forest Investigative Site 033
Cherry Hill, New Jersey, United States, 08002
United States, New Mexico
Forest Investigative Site 040
Albuquerque, New Mexico, United States, 87108
United States, New York
Forest Investigative Site 035
Great Neck, New York, United States, 11021
Forest Investigative Site 014
Rochester, New York, United States, 14618
Forest Investigative Site 027
Syracuse, New York, United States, 13210
United States, North Carolina
Forest Investigative Site 054
Charlotte, North Carolina, United States, 28209
Forest Investigative Site 018
Greensboro, North Carolina, United States, 27408
Forest Investigative Site 002
Greenville, North Carolina, United States, 27834
Forest Investigative Site 024
Salisbury, North Carolina, United States, 28144
Forest Investigative Site 042
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Forest Investigative Site 003
Cincinnati, Ohio, United States, 45219
Forest Investigative Site 005
Cleveland, Ohio, United States, 44122
Forest Investigative Site 059
Columbus, Ohio, United States, 43212
United States, Oregon
Forest Investigative Site 044
Eugene, Oregon, United States, 97401
Forest Investigative Site 010
Eugene, Oregon, United States, 97404
Forest Investigative Site 052
Medford, Oregon, United States, 97504
Forest Investigative Site 001
Medford, Oregon, United States, 97504
Forest Investigative Site 041
Portland, Oregon, United States, 97205
United States, Pennsylvania
Forest Investigative Site 051
Duncansville, Pennsylvania, United States, 16635
Forest Investigative Site 046
Mechanicsburg, Pennsylvania, United States, 17055
United States, South Carolina
Forest Investigative Site 028
Anderson, South Carolina, United States, 29621
Forest Investigative Site 021
Greer, South Carolina, United States, 29651
United States, Utah
Forest Investigative Site 006
Salt Lake City, Utah, United States, 84102
United States, Virginia
Forest Investigative Site 015
Chesapeake, Virginia, United States, 23320
United States, Washington
Forest Investigative Site 047
Seattle, Washington, United States, 98104
Forest Investigative Site 036
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Forest Investigative Site 063
Racine, Wisconsin, United States, 53406
Sponsors and Collaborators
Forest Laboratories
Cypress Bioscience, Inc.
Investigators
Study Director: Joel Trugman, MD Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc
  More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01014585     History of Changes
Other Study ID Numbers: MLN-MD-27
Study First Received: November 13, 2009
Results First Received: June 7, 2011
Last Updated: September 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Milnacipran
Pain
Durability of Effect
Loss of Therapeutic Response
Fatigue
Forest Research Institute
Savella ®

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Milnacipran
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014