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An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Buccal Film (DBF) in Pediatric, Adolescent and Adult Subjects With Epilepsy

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Trial Profile

An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Buccal Film (DBF) in Pediatric, Adolescent and Adult Subjects With Epilepsy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2021

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At a glance

  • Drugs Diazepam (Primary)
  • Indications Epilepsy; Seizures
  • Focus Adverse reactions; Registrational
  • Sponsors Aquestive Therapeutics
  • Most Recent Events

    • 25 Aug 2020 Status changed from active, no longer recruiting to completed.
    • 01 May 2020 Results (as of May 2019; n=72) assessing safety and tolerability of diazepam buccal film (DBF) in pediatric, adolescent, and adult patients with epilepsy experiencing seizure emergency, presented at the 72nd Annual Meeting of the American Academy of Neurology.
    • 31 Mar 2020 Planned End Date changed from 30 Apr 2020 to 1 Nov 2020.
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