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A Seamless, Clinical Trial to Investigate the Safety and Efficacy of Multiple Doses of PRAX-222 in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy

Trial Profile

A Seamless, Clinical Trial to Investigate the Safety and Efficacy of Multiple Doses of PRAX-222 in Pediatric Participants with Early Onset SCN2A Developmental and Epileptic Encephalopathy

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Mar 2025

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At a glance

  • Drugs Elsunersen (Primary)
  • Indications Encephalopathy; Epilepsy
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms EMBRAVE
  • Sponsors Praxis Precision Medicines

Most Recent Events

  • 28 Feb 2025 According to a Praxis Precision Medicines media release, The second cohort of the EMBRAVE study evaluating safety and efficacy of elsunersen versus sham procedure continues enrolling patients in Brazil, with topline readout anticipated in the first half of 2026.
  • 13 Jan 2025 Results from Part 1 analysis of the EMBRAVE study presented in the Praxis Precision Medicines Media Release.
  • 04 Oct 2024 Planned End Date changed from 1 Feb 2026 to 1 Sep 2027.

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