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

September 2, 2011 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Savella ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Loss of Therapeutic Response (LTR)
Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Worsening in Patient Global Impression of Change (PGIC)
Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17)
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)
Time to Worsening in Multidimensional Assessment of Fatigue (MAF)
Time Frame: From baseline Visit 3 (week 5) to Visit 7 (week 17)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

Cypress Bioscience, Inc.

Investigators

  • Study Director: Joel Trugman, MD, Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 17, 2009

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 2, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLN-MD-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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