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A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy With Vigabatrin as Initial Therapy in Patients With Infantile Spasms

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Trial Profile

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy With Vigabatrin as Initial Therapy in Patients With Infantile Spasms

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2023

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At a glance

  • Drugs Cannabidiol (Primary) ; Vigabatrin
  • Indications Infantile spasms
  • Focus Registrational; Therapeutic Use
  • Sponsors Benuvia Therapeutics; INSYS Therapeutics, Inc; Radius

    • Most Recent Events

    • 11 May 2023 Status changed from active, no longer recruiting to discontinued.
    • 16 May 2019 Status changed from recruiting to active, no longer recruiting.
    • 17 Dec 2018 According to an INSYS Therapeutics, Inc. media release, enrollment in the study of infantile spasms has occurred at a slower pace than anticipated, and the company will provide an update once it has better visibility into enrollment.
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