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

Status

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

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.

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

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.
116

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 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

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

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

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.
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

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 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

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
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

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: 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)

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.
April 30, 2011

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.
August 31, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2012

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).
March 31, 2011

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.
April 1, 2011

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.
April 4, 2011

Study Record Updates

Last Update Posted (Actual)

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.
May 14, 2019

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.
April 23, 2019

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.
March 1, 2019

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-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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