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

Stopped early · Phase 2

Conditions studied: Primary Fibromyalgia

In brief

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.

Key facts

Study ID

NCT01331109

Run by

Forest Laboratories

People needed

57

Starts

2011-04-01

Expected to finish

2012-08-01

Last updated by the study team

2013-09-30

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Forest Investigative Site 040 — Birmingham, Alabama, United States
• Forest Investigative Site 033 — Bullhead City, Arizona, United States
• Forest Investigative Site 012 — Fresno, California, United States
• Forest Investigative Site 045 — Fresno, California, United States
• Forest Investigative Site 051 — Fresno, California, United States
• Forest Investigative Site 035 — Orange, California, United States
• Forest Investigative Site 053 — Orange, California, United States
• Forest Investigative Site 050 — Sacramento, California, United States
• Forest Investigative Site 034 — Colorado Springs, Colorado, United States
• Forest Investigative Site 014 — Spring Hill, Florida, United States
• Forest Investigative Site 055 — West Palm Beach, Florida, United States
• Forest Investigative Site 058 — Blue Ridge, Georgia, United States
• Forest Investigative Site 010 — Peoria, Illinois, United States
• Forest Investigative Site 017 — Louisville, Kentucky, United States
• Forest Investigative Site 009 — Ann Arbor, Michigan, United States
• Forest Investigative Site 024 — Rochester Hills, Michigan, United States
• Forest Investigative Site 036 — Stevensville, Michigan, United States
• Forest Investigative Site 049 — Whitehouse Station, New Jersey, United States
• Forest Investigative Site 018 — Albuquerque, New Mexico, United States
• Forest Investigative Site 062 — Raleigh, North Carolina, United States
• Forest Investigative Site 052 — Winston-Salem, North Carolina, United States
• Forest Investigative Site 016 — Cincinnati, Ohio, United States
• Forest Investigative Site 015 — Dayton, Ohio, United States
• Forest Investigative Site 046 — Greer, South Carolina, United States
• Forest Investigative Site 023 — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.