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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies

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Trial Profile

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies

Recruiting
Phase of Trial: Phase II

Latest Information Update: 18 Feb 2019

At a glance

  • Drugs TAK 935 (Primary)
  • Indications Dravet syndrome; Lennox-Gastaut syndrome
  • Focus Therapeutic Use
  • Acronyms ELEKTRA
  • Sponsors Takeda

    • Most Recent Events

    • 17 Dec 2018 According to the Ovid Therapeutics media release, the company will amend the protocols for this study to exclude patients being treated with perampanel and, in light of the mode of action of OV935, the duration of treatment will be extended with the potential to observe the extent of the effects of OV935 on seizure reduction over time.
    • 25 Sep 2018 Planned End Date changed from 21 Mar 2021 to 21 Apr 2021.
    • 24 Sep 2018 According to an Ovid Therapeutics media release, the first patient has been randomized to receive either OV935 or placebo in this trial.
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