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Long-Term Safety and Efficacy Study 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
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

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran

Exclusion Criteria:

  • Can not tolerate a minimum daily dose of 50mg milnacipran
  • Significant risk of suicidality
  • Pregnant or breastfeeding

Sites / Locations

  • Forest Investigative Site 040
  • 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 014
  • Forest Investigative Site 055
  • Forest Investigative Site 058
  • Forest Investigative Site 010
  • 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 016
  • Forest Investigative Site 015
  • 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 063
  • Forest Investigative Site 004

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Milnacipran

Arm Description

oral administration, twice daily dosing

Outcomes

Primary Outcome Measures

Adverse Events
Number of Patients who experience one or more treatment emergent adverse event (TEAE)

Secondary Outcome Measures

Full Information

First Posted
March 31, 2011
Last Updated
July 31, 2013
Sponsor
Forest Laboratories
Collaborators
Cypress Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01331109
Brief Title
Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Acronym
MyFi
Official Title
A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 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 long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Milnacipran
Arm Type
Experimental
Arm Description
oral administration, twice daily dosing
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Intervention Description
maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of Patients who experience one or more treatment emergent adverse event (TEAE)
Time Frame
Baseline (Visit 1) to Week 53 (Visit 9)
Other Pre-specified Outcome Measures:
Title
Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Description
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: Level 1: Wish to be Dead Level 2: Non-Specific Active Suicidal Thoughts Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan Level 5: Active Suicidal Ideation with Specific Plan and Intent
Time Frame
Baseline (Visit 1) to Week 53 (Visit 9)
Title
Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Description
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: Level 1: Wish to be Dead Level 2: Non-Specific Active Suicidal Thoughts Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan Level 5: Active Suicidal Ideation with Specific Plan and Intent
Time Frame
Baseline (Visit 1) to Week 53 (Visit 9)
Title
Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Description
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: Level 1: Wish to be Dead Level 2: Non-Specific Active Suicidal Thoughts Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan Level 5: Active Suicidal Ideation with Specific Plan and Intent
Time Frame
Baseline (Visit 1) to Week 53 (Visit 9)
Title
Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Description
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: Level 1: Wish to be Dead Level 2: Non-Specific Active Suicidal Thoughts Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan Level 5: Active Suicidal Ideation with Specific Plan and Intent
Time Frame
Baseline (Visit 1) to Week 53 (Visit 9)
Title
Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Description
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity: Level 1: Wish to be Dead Level 2: Non-Specific Active Suicidal Thoughts Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan Level 5: Active Suicidal Ideation with Specific Plan and Intent
Time Frame
Baseline (Visit 1) to Week 53 (Visit 9)
Title
Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
Description
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are: Preparatory acts or behavior Aborted attempt Interrupted attempt Actual attempt Completed suicide attempt
Time Frame
Baseline (Visit 1) to Week 53 (Visit 9)

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: Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran Exclusion Criteria: Can not tolerate a minimum daily dose of 50mg milnacipran Significant risk of suicidality Pregnant or breastfeeding
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 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 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 010
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
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 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 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 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

Learn more about this trial

Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia

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