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A Phase II/III trial to Evaluate the Efficacy of NBI-921352 (formerly XEN901) in SCN8A Developmental and Epileptic Encephalopathy (SCN8A-DEE) Pediatric Patients

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Trial Profile

A Phase II/III trial to Evaluate the Efficacy of NBI-921352 (formerly XEN901) in SCN8A Developmental and Epileptic Encephalopathy (SCN8A-DEE) Pediatric Patients

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 12 Feb 2021

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At a glance

  • Drugs NBI 921352 (Primary)
  • Indications Encephalopathy; Epilepsy
  • Focus Therapeutic Use
  • Sponsors Xenon Pharmaceuticals

Most Recent Events

  • 04 Feb 2021 According to a Neurocrine Biosciences media release, based on feedback received in January 2021, the company plans to initiate this Phase II clinical study in adolescent patients (aged 12 years and older) with SCN8A-DEE in the third quarter of 2021, and the study protocol will be amended to include younger pediatric patients (aged 2-11 years) with SCN8A-DEE as soon as the FDA has reviewed and approved additional non-clinical information.
  • 08 Oct 2020 According to a Neurocrine Biosciences, Xenon Pharmaceuticals media release, the companies will engage with the FDA to address the feedback received with the goal of initiating this trial in 2021.
  • 08 Oct 2020 According to a Neurocrine Biosciences, Xenon Pharmaceuticals media release, the U.S. Food and Drug Administration(FDA) provided feedback on an Investigational New Drug (IND) application submitted to support this Phase II trial in pediatric SCN8A-DEE patients. As part of its review of the IND, the FDA is requesting additional non-clinical data to support dose justification in this study.

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