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A Phase 2,Double-Blind,Randomized Clinical Trial to Explore the Safety,Tolerability,Efficacy, and Pharmacokinetics of PRAX-562 in Pediatric Participants With Developmental and Epileptic Encephalopathies Followed by Open-Label Extension(OLE)

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Trial Profile

A Phase 2,Double-Blind,Randomized Clinical Trial to Explore the Safety,Tolerability,Efficacy, and Pharmacokinetics of PRAX-562 in Pediatric Participants With Developmental and Epileptic Encephalopathies Followed by Open-Label Extension(OLE)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Relutrigine (Primary) ; Relutrigine (Primary)
  • Indications Encephalopathy; Epilepsy; Seizures
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms EMBOLD
  • Sponsors Praxis Precision Medicines

Most Recent Events

  • 05 May 2025 According to Praxis Precision Medicines media release, company presented trial design details from this trial, hosted a virtual investor event on its clinical programs in developmental and epileptic encephalopathies (DEEs) on Friday, May 2, 2025.
  • 08 Apr 2025 According to a Praxis Precision Medicines media release, the company to host a virtual investor event on Friday, May 2, 2025 to give update on this trial.
  • 28 Jan 2025 The protocol has been amended to change the Phase of the study to phase II/III and the primary endpoints has been changed due to which overall trial focus has been changed to TU. Planned patient numbers are increased as well to 100.

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