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Bioequivalence study of extended-release topiramate ( SPN-538) versus immediate-release topiramate at steady state.

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Trial Profile

Bioequivalence study of extended-release topiramate ( SPN-538) versus immediate-release topiramate at steady state.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 Sep 2016

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At a glance

  • Drugs Topiramate (Primary) ; Topiramate (Primary) ; Topiramate (Primary) ; Topiramate (Primary)
  • Indications Epilepsy
  • Focus Pharmacokinetics
  • Sponsors Supernus Pharmaceuticals

    • Most Recent Events

    • 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.

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