Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia
- Registration Number
- NCT01331109
- Lead Sponsor
- Forest Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 57
- Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran
- Can not tolerate a minimum daily dose of 50mg milnacipran
- Significant risk of suicidality
- Pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Milnacipran Milnacipran oral administration, twice daily dosing
- Primary Outcome Measures
Name Time Method Adverse Events Baseline (Visit 1) to Week 53 (Visit 9) Number of Patients who experience one or more treatment emergent adverse event (TEAE)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
Forest Investigative Site 042
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 063
🇺🇸Seattle, Washington, United States
Forest Investigative Site 017
🇺🇸Louisville, Kentucky, United States
Forest Investigative Site 045
🇺🇸Fresno, California, United States
Forest Investigative Site 010
🇺🇸Peoria, Illinois, United States
Forest Investigative Site 053
🇺🇸Orange, California, United States
Forest Investigative Site 034
🇺🇸Colorado Springs, Colorado, United States
Forest Investigative Site 012
🇺🇸Fresno, California, United States
Forest Investigative Site 051
🇺🇸Fresno, California, United States
Forest Investigative Site 033
🇺🇸Bullhead City, Arizona, United States
Forest Investigative Site 024
🇺🇸Rochester Hills, Michigan, United States
Forest Investigative Site 014
🇺🇸Spring Hill, Florida, United States
Forest Investigative Site 050
🇺🇸Sacramento, California, United States
Forest Investigative Site 025
🇺🇸Clinton, Utah, United States
Forest Investigative Site 055
🇺🇸West Palm Beach, Florida, United States
Forest Investigative Site 058
🇺🇸Blue Ridge, Georgia, United States
Forest Investigative Site 016
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 015
🇺🇸Dayton, Ohio, United States
Forest Investigative Site 009
🇺🇸Ann Arbor, Michigan, United States
Forest Investigative Site 013
🇺🇸Salt Lake City, Utah, United States
Forest Investigative Site 062
🇺🇸Raleigh, North Carolina, United States
Forest Investigative Site 052
🇺🇸Winston-Salem, North Carolina, United States
Forest Investigative Site 040
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 035
🇺🇸Orange, California, United States
Forest Investigative Site 003
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 004
🇺🇸Racine, Wisconsin, United States
Forest Investigative Site 036
🇺🇸Stevensville, Michigan, United States
Forest Investigative Site 049
🇺🇸Whitehouse Station, New Jersey, United States
Forest Investigative Site 046
🇺🇸Greer, South Carolina, United States
Forest Investigative Site 018
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 023
🇺🇸Austin, Texas, United States