Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia — MyFi

Primary Fibromyalgia Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Status Terminated

Clinical Trial 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.

Clinical Trial Description

- 8 weeks open-label treatment period with milnacipran.

- Followed by randomization to 8-weeks double blind treatment period for eligible patients ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01328002
Study type	Interventional
Source	Forest Laboratories
Contact
Status	Terminated
Phase	Phase 2
Start date	April 30, 2011
Completion date	August 31, 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01903265` - BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)	Phase 2/Phase 3
Completed	`NCT03783910` - Efficacy and Safety of GRT9906 Tablets Compared to Placebo in Patients With Fibromyalgia	Phase 2
Completed	`NCT02015234` - 12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients	Phase 3
Terminated	`NCT02589275` - A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients	Phase 3
Completed	`NCT01820052` - A Randomized Trial of Oral Iron Therapy in Fibromyalgia	Phase 3
Terminated	`NCT01331109` - Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia	Phase 2