Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia (MyFi)

April 23, 2019 updated by: Forest Laboratories

A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

  • 8 weeks open-label treatment period with milnacipran.
  • Followed by randomization to 8-weeks double blind treatment period for eligible patients

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2

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 040
      • Birmingham, Alabama, United States, 35216
        • Forest Investigative Site 068
    • Arizona
      • Bullhead City, Arizona, United States, 86442
        • Forest Investigative Site 033
    • California
      • Fresno, California, United States, 93710
        • Forest Investigative Site 012
      • Fresno, California, United States, 93720
        • Forest Investigative Site 045
      • Fresno, California, United States, 93721
        • Forest Investigative Site 051
      • Orange, California, United States, 92868
        • Forest Investigative Site 035
      • Orange, California, United States, 92868
        • Forest Investigative Site 053
      • Sacramento, California, United States, 95825
        • Forest Investigative Site 050
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Forest Investigative Site 034
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Forest Investigative Site 047
    • Florida
      • Gainesville, Florida, United States, 32607
        • Forest Investigative Site 061
      • Orange City, Florida, United States, 32763
        • Forest Investigative Site 041
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 059
      • Spring Hill, Florida, United States, 34609
        • Forest Investigative Site 014
      • West Palm Beach, Florida, United States, 33409
        • Forest Investigative Site 055
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
        • Forest Investigative Site 058
      • Savannah, Georgia, United States, 31406
        • Forest Investigative Site 031
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Forest Investigative Site 022
      • Peoria, Illinois, United States, 61614
        • Forest Investigative Site 010
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Forest Investigative Site 005
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Forest Investigative Site 017
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Forest Investigative Site 009
      • Rochester Hills, Michigan, United States, 48307
        • Forest Investigative Site 024
      • Stevensville, Michigan, United States, 49127
        • Forest Investigative Site 036
    • New Jersey
      • Whitehouse Station, New Jersey, United States, 08889
        • Forest Investigative Site 049
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Forest Investigative Site 018
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Forest Investigative Site 062
      • Winston-Salem, North Carolina, United States, 27103
        • Forest Investigative Site 052
    • Ohio
      • Akron, Ohio, United States, 44308
        • Forest Investigative Site 038
      • Cincinnati, Ohio, United States, 45219
        • Forest Investigative Site 016
      • Dayton, Ohio, United States, 45432
        • Forest Investigative Site 015
      • Middleburg Heights, Ohio, United States, 44130
        • Forest Investigative Site 019
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Forest Investigative Site 001
      • Oklahoma City, Oklahoma, United States, 73112
        • Forest Investigative Site 027
    • Pennsylvania
      • Mechanicsburg, Pennsylvania, United States, 17055
        • Forest Investigative Site 066
      • Philadelphia, Pennsylvania, United States, 19139
        • Forest Investigative Site 054
    • South Carolina
      • Greer, South Carolina, United States, 29650
        • Forest Investigative Site 046
    • Texas
      • Austin, Texas, United States, 78732
        • Forest Investigative Site 023
      • San Antonio, Texas, United States, 78215
        • Forest Investigative Site 003
      • San Antonio, Texas, United States, 78258
        • Forest Investigative Site 042
    • Utah
      • Clinton, Utah, United States, 84015
        • Forest Investigative Site 025
      • Salt Lake City, Utah, United States, 84102
        • Forest Investigative Site 013
    • Virginia
      • Lynchburg, Virginia, United States, 24503
        • Forest Investigative Site 021
    • Washington
      • Bellevue, Washington, United States, 98007
        • Forest Investigative Site 006
      • Seattle, Washington, United States, 98104
        • Forest Investigative Site 063
    • Wisconsin
      • Racine, Wisconsin, United States, 53406
        • Forest Investigative Site 004

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

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of primary fibromyalgia
  • 13-17 years of age
  • To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale
  • To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2)
  • To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2)
  • Unsatisfactory response to nonpharmacologic fibromyalgia treatment.

Exclusion Criteria:

  • Severe psychiatric illness
  • Severe renal impairment
  • Evidence of active liver disease
  • Pregnant or breastfeeding
  • Significant risk of suicidality
  • Unable, unwilling or inadvisable to discontinue prohibited medications
  • History of alcohol abuse or drug abuse or dependence, within previous year
  • Current systemic infection
  • Autoimmune disease
  • History of seizure disorder (other than febrile seizures)

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
Experimental: Milnacipran
oral administration, twice daily dosing
Drug: Milnacipran

Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open label phase of the study.

Oral administration, twice daily dosing

Other Names:
  • Savella
Placebo Comparator: Placebo
oral administration, twice daily dosing
Drug: Placebo
matching placebo tablets daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
Time Frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16)
During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline (Visit 2) OR • Withdrawal from the study for any reason except withdrawals due to extenuating circumstances
Change from Visit 7 (Week 8) to Visit 10 (Week 16)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Severity (PGIS)
Time Frame: Change from Visit 7 (Week 8) to Visit 10 (Week 16)
The wording of the PGIS assessment was as follows: "Considering all aspects of your illness, how do you evaluate the severity of your fibromyalgia?" The possible responses to this question were 1. Normal, not at all ill 2. Borderline ill 3. Mildly ill 4. Moderately ill 5. Severely ill 6. Extremely ill
Change from Visit 7 (Week 8) to Visit 10 (Week 16)

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: Patricia M D'Astoli, LPN, Forest Laboratories

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 (Actual)

April 30, 2011

Primary Completion (Actual)

August 31, 2012

Study Completion (Actual)

August 31, 2012

Study Registration Dates

First Submitted

March 31, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (Estimate)

April 4, 2011

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLN-MD-14

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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