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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Forest Laboratories

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cypress Bioscience, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Fibromyalgia

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings