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A multi-dose Phase 1b to evaluate the tolerability and PK profile of three ascending doses of ADS-4101 administered once daily at bedtime compared to ascending doses of twice daily VIMPAT tablets

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Trial Profile

A multi-dose Phase 1b to evaluate the tolerability and PK profile of three ascending doses of ADS-4101 administered once daily at bedtime compared to ascending doses of twice daily VIMPAT tablets

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 May 2018

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At a glance

  • Drugs Lacosamide (Primary) ; Lacosamide
  • Indications Epilepsy
  • Focus Adverse reactions; Pharmacokinetics

    • Most Recent Events

    • 27 Apr 2018 Results of two phase 1 studies (CTP: 278641 and CTP:285253) assessing pharmacokinetic evaluations of ADS-4101 (Lacosamide) Modified Release Capsules versus Lacosamide immediate release presented presented at the 70th Annual Meeting of the American Academy of Neurology.
    • 05 Dec 2017 Status changed from recruiting to completed, according to results presented at the 71st Annual Meeting of the American Epilepsy Society.
    • 05 Dec 2017 Results presented at the 71st Annual Meeting of the American Epilepsy Society.

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