NCT01328002

Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* 8 weeks open-label treatment period with milnacipran. * Followed by randomization to 8-weeks double blind treatment period for eligible patients

Conditions

• Primary Fibromyalgia

Interventions

Type	Name	Description
DRUG	Milnacipran	Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open label phase of the study. Oral administration, twice daily dosing
DRUG	Placebo	matching placebo tablets daily

Timeline

• Start date: 2011-04-30
• Primary completion: 2012-08-31
• Completion: 2012-08-31
• First posted: 2011-04-04
• Last updated: 2019-05-14
• Results posted: 2019-05-14

Locations

47 sites across 1 country: United States