Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113815
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2005-06-10
Brief Title:
Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Fixed Dose-Ranging Study to Assess the Safety Tolerability and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants 1-24 Months of Age With Refractory Partial-Onset Seizures
Status:
COMPLETED
Status Verified Date:
2014-03
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:
None
Brief Summary:
The purpose of this study is to evaluate the tolerability safety and efficacy of topiramate in infants with refractory partial onset seizures POS
Detailed Description:
This is a world wide multicenter randomized double-blind placebo-controlled study to evaluate the tolerability safety and efficacy of 3 target doses 5 15 and 25 mgkgday of topiramate compared with placebo as an adjunct therapy in infants with refractory partial onset seizures POS There are 4 phases to the study a screening phase of 3 days a double blind treatment phase of 20 days a one year open label extension phase and a posttreatment taper and withdrawal phase The oral liquid formulation will also be assessed during this study as it is investigational unlike the marketed sprinkle formulation 5 15 25 mgkgday of topriramate sprinkle and oral liquid formulation will be administered during the four phases of the study
Study Oversight
Has Oversight DMC:
None
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?:
None