Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia
MyFi
A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
1 other identifier
interventional
57
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2011
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
September 30, 2013
CompletedSeptember 30, 2013
July 1, 2013
1.3 years
March 31, 2011
July 31, 2013
July 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
Number of Patients who experience one or more treatment emergent adverse event (TEAE)
Baseline (Visit 1) to Week 53 (Visit 9)
Other Outcomes (6)
Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Baseline (Visit 1) to Week 53 (Visit 9)
Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Baseline (Visit 1) to Week 53 (Visit 9)
Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).
Baseline (Visit 1) to Week 53 (Visit 9)
- +3 more other outcomes
Study Arms (1)
Milnacipran
EXPERIMENTALoral administration, twice daily dosing
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran
You may not qualify if:
- Can not tolerate a minimum daily dose of 50mg milnacipran
- Significant risk of suicidality
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Forest Laboratorieslead
- Cypress Bioscience, Inc.collaborator
Study Sites (31)
Forest Investigative Site 040
Birmingham, Alabama, 35205, United States
Forest Investigative Site 033
Bullhead City, Arizona, 86442, United States
Forest Investigative Site 012
Fresno, California, 93710, United States
Forest Investigative Site 045
Fresno, California, 93720, United States
Forest Investigative Site 051
Fresno, California, 93721, United States
Forest Investigative Site 035
Orange, California, 92868, United States
Forest Investigative Site 053
Orange, California, 92868, United States
Forest Investigative Site 050
Sacramento, California, 95825, United States
Forest Investigative Site 034
Colorado Springs, Colorado, 80907, United States
Forest Investigative Site 014
Spring Hill, Florida, 34609, United States
Forest Investigative Site 055
West Palm Beach, Florida, 33409, United States
Forest Investigative Site 058
Blue Ridge, Georgia, 30513, United States
Forest Investigative Site 010
Peoria, Illinois, 61614, United States
Forest Investigative Site 017
Louisville, Kentucky, 40202, United States
Forest Investigative Site 009
Ann Arbor, Michigan, 48104, United States
Forest Investigative Site 024
Rochester Hills, Michigan, 48307, United States
Forest Investigative Site 036
Stevensville, Michigan, 49127, United States
Forest Investigative Site 049
Whitehouse Station, New Jersey, 08889, United States
Forest Investigative Site 018
Albuquerque, New Mexico, 87109, United States
Forest Investigative Site 062
Raleigh, North Carolina, 27612, United States
Forest Investigative Site 052
Winston-Salem, North Carolina, 27103, United States
Forest Investigative Site 016
Cincinnati, Ohio, 45219, United States
Forest Investigative Site 015
Dayton, Ohio, 45432, United States
Forest Investigative Site 046
Greer, South Carolina, 29650, United States
Forest Investigative Site 023
Austin, Texas, 78732, United States
Forest Investigative Site 003
San Antonio, Texas, 78215, United States
Forest Investigative Site 042
San Antonio, Texas, 78258, United States
Forest Investigative Site 025
Clinton, Utah, 84015, United States
Forest Investigative Site 013
Salt Lake City, Utah, 84102, United States
Forest Investigative Site 063
Seattle, Washington, 98104, United States
Forest Investigative Site 004
Racine, Wisconsin, 53406, United States
Related Publications (1)
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.
PMID: 26112278DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early, resulting in a small number of patients analyzed. Only descriptive statistics were presented.
Results Point of Contact
- Title
- Robert Palmer, MD
- Organization
- Forest Research Institute
Study Officials
- STUDY DIRECTOR
Patricia M D'Astoli, LPN
Forest Laboratories
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2011
First Posted
April 7, 2011
Study Start
April 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
September 30, 2013
Results First Posted
September 30, 2013
Record last verified: 2013-07