Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Phase 2 Terminated 116 enrolled Forest Laboratories Cypress Bioscience, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.

Timeline

Start: 2011-04-30
Primary completion: 2012-08-31
Completion: 2012-08-31

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

Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Summary

Timeline

Publications

Drugs

Indications