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

Phase 2 Terminated 57 enrolled Forest Laboratories Cypress Bioscience, Inc. · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2011-04
Primary completion: 2012-08
Completion: 2012-08

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Because only 20 patients were randomized into the double-blind withdrawal period, statistical analyses were not conducted for the LTR endpoint. PMID 26112278 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Milnacipran	Other / unclassified	50 mg	Oral
Subject	Milnacipran	Other / unclassified	75 mg	Oral
Subject	Milnacipran	Other / unclassified	100 mg	Oral