Bioequivalence study of extended-release topiramate ( SPN-538) versus immediate-release topiramate at steady state.
Phase of Trial: Phase I
Latest Information Update: 12 Jun 2016
At a glance
- Drugs Topiramate (Primary) ; Topiramate (Primary)
- Indications Epilepsy
- Focus Pharmacokinetics
- Sponsors Supernus Pharmaceuticals
- 21 Apr 2015 Results of a pooled analysis of the negative effects of topiramate on verbal fluency in the IV/IR study (profile 700234568) and the SPN-538/IR study (profile 210651) were presented at the 67th Annual Meeting of the American Academy of Neurology.
- 06 Nov 2013 Cognitive function results will be presented at the Annual Meeting of the American Epilepsy Society (AES) in December 2013.
- 08 Dec 2011 Primary endpoint of bioequivalence met as reported by results presented at the 65th Annual Meeting of the American Epilepsy Society.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History