Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT01328002
Status:
TERMINATED
Last Update Posted:
2019-05-14
First Post:
2011-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Sponsor:
Forest Laboratories
Organization:
Study Overview
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
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MyFi
Brief 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
* Followed by randomization to 8-weeks double blind treatment period for eligible patients
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: