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Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

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Trial Profile

Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Oct 2023

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At a glance

  • Drugs Apinocaltamide (Primary)
  • Indications Encephalopathy; Epilepsy
  • Focus Therapeutic Use
  • Acronyms STEAMBOAT
  • Sponsors Idorsia Pharmaceuticals; Neurocrine Biosciences

    • Most Recent Events

    • 06 Dec 2022 Results published in the Neurocrine Biosciences Media Release.
    • 06 Dec 2022 Primary endpoint has not been met. (Ratio of spike-wave index (SWI) during first hour of nonrapid eye movement (NREM) sleep based on centralized video-EEG reading.), according to a Neurocrine Biosciences media release.
    • 09 Nov 2022 Status changed from active, no longer recruiting to completed.

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