Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-02 @ 7:40 AM
Study NCT ID:
NCT00772603
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2008-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
Sponsor:
Supernus Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Status:
COMPLETED
Status Verified Date:
2013-12
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:
PROSPER1
Brief Summary:
Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures
Detailed Description:
Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.
Study Oversight
Has Oversight DMC:
False
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?: