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

Primary Purpose

Primary Fibromyalgia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Milnacipran
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Fibromyalgia focused on measuring Fibromyalgia, Pediatric Fibromyalgia, Adolescent Fibromyalgia, milnacipran, Savella, loss of therapeutic response, Forest Research Institute, Pain, Fatigue, Serotonin Norepinephrine Reuptake Inhibitors, Randomized Withdrawal

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Forest Investigative Site 040
  • Forest Investigative Site 068
  • Forest Investigative Site 033
  • Forest Investigative Site 012
  • Forest Investigative Site 045
  • Forest Investigative Site 051
  • Forest Investigative Site 035
  • Forest Investigative Site 053
  • Forest Investigative Site 050
  • Forest Investigative Site 034
  • Forest Investigative Site 047
  • Forest Investigative Site 061
  • Forest Investigative Site 041
  • Forest Investigative Site 059
  • Forest Investigative Site 014
  • Forest Investigative Site 055
  • Forest Investigative Site 058
  • Forest Investigative Site 031
  • Forest Investigative Site 022
  • Forest Investigative Site 010
  • Forest Investigative Site 005
  • Forest Investigative Site 017
  • Forest Investigative Site 009
  • Forest Investigative Site 024
  • Forest Investigative Site 036
  • Forest Investigative Site 049
  • Forest Investigative Site 018
  • Forest Investigative Site 062
  • Forest Investigative Site 052
  • Forest Investigative Site 038
  • Forest Investigative Site 016
  • Forest Investigative Site 015
  • Forest Investigative Site 019
  • Forest Investigative Site 001
  • Forest Investigative Site 027
  • Forest Investigative Site 066
  • Forest Investigative Site 054
  • Forest Investigative Site 046
  • Forest Investigative Site 023
  • Forest Investigative Site 003
  • Forest Investigative Site 042
  • Forest Investigative Site 025
  • Forest Investigative Site 013
  • Forest Investigative Site 021
  • Forest Investigative Site 006
  • Forest Investigative Site 063
  • Forest Investigative Site 004

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Milnacipran

Placebo

Arm Description

oral administration, twice daily dosing

oral administration, twice daily dosing

Outcomes

Primary Outcome Measures

Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
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

Secondary Outcome Measures

Patient Global Impression of Severity (PGIS)
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

Full Information

First Posted
March 31, 2011
Last Updated
April 23, 2019
Sponsor
Forest Laboratories
Collaborators
Cypress Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01328002
Brief Title
Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Acronym
MyFi
Official Title
A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Study Start Date
April 30, 2011 (Actual)
Primary Completion Date
August 31, 2012 (Actual)
Study Completion Date
August 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Cypress Bioscience, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
8 weeks open-label treatment period with milnacipran. Followed by randomization to 8-weeks double blind treatment period for eligible patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Fibromyalgia
Keywords
Fibromyalgia, Pediatric Fibromyalgia, Adolescent Fibromyalgia, milnacipran, Savella, loss of therapeutic response, Forest Research Institute, Pain, Fatigue, Serotonin Norepinephrine Reuptake Inhibitors, Randomized Withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Milnacipran
Arm Type
Experimental
Arm Description
oral administration, twice daily dosing
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
oral administration, twice daily dosing
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Other Intervention Name(s)
Savella
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo tablets daily
Primary Outcome Measure Information:
Title
Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.
Description
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
Time Frame
Change from Visit 7 (Week 8) to Visit 10 (Week 16)
Secondary Outcome Measure Information:
Title
Patient Global Impression of Severity (PGIS)
Description
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
Time Frame
Change from Visit 7 (Week 8) to Visit 10 (Week 16)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia M D'Astoli, LPN
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 040
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Forest Investigative Site 068
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Forest Investigative Site 033
City
Bullhead City
State/Province
Arizona
ZIP/Postal Code
86442
Country
United States
Facility Name
Forest Investigative Site 012
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Forest Investigative Site 045
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Forest Investigative Site 051
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Forest Investigative Site 035
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigative Site 053
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigative Site 050
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Forest Investigative Site 034
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Forest Investigative Site 047
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Forest Investigative Site 061
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Forest Investigative Site 041
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Forest Investigative Site 059
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 014
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Forest Investigative Site 055
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Forest Investigative Site 058
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Forest Investigative Site 031
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Forest Investigative Site 022
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Forest Investigative Site 010
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Forest Investigative Site 005
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Forest Investigative Site 017
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Forest Investigative Site 009
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Forest Investigative Site 024
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Forest Investigative Site 036
City
Stevensville
State/Province
Michigan
ZIP/Postal Code
49127
Country
United States
Facility Name
Forest Investigative Site 049
City
Whitehouse Station
State/Province
New Jersey
ZIP/Postal Code
08889
Country
United States
Facility Name
Forest Investigative Site 018
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Forest Investigative Site 062
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Forest Investigative Site 052
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Forest Investigative Site 038
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Forest Investigative Site 016
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 015
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Forest Investigative Site 019
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Forest Investigative Site 001
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 027
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 066
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Forest Investigative Site 054
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Forest Investigative Site 046
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Forest Investigative Site 023
City
Austin
State/Province
Texas
ZIP/Postal Code
78732
Country
United States
Facility Name
Forest Investigative Site 003
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Forest Investigative Site 042
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Forest Investigative Site 025
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Forest Investigative Site 013
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Forest Investigative Site 021
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24503
Country
United States
Facility Name
Forest Investigative Site 006
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 063
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Forest Investigative Site 004
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53406
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26112278
Citation
Arnold LM, Bateman L, Palmer RH, Lin Y. Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program. Pediatr Rheumatol Online J. 2015 Jun 26;13:27. doi: 10.1186/s12969-015-0025-9.
Results Reference
derived

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Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

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