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A phase 3 pivotal study of XEN496, a Kv7 potassium channel modulator for the potential treatment of KCNQ2 epileptic encephalopathy

Trial Profile

A phase 3 pivotal study of XEN496, a Kv7 potassium channel modulator for the potential treatment of KCNQ2 epileptic encephalopathy

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2019

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At a glance

  • Drugs Retigabine (Primary)
  • Indications Epilepsy
  • Focus Registrational; Therapeutic Use
  • Sponsors Xenon Pharmaceuticals
  • Most Recent Events

    • 05 Nov 2019 According to a Xenon Pharmaceuticals media release, the company expects to initiate this trial in 2020.
    • 06 Mar 2019 According to a Xenon Pharmaceuticals media release, the company expects to file an Investigational New Drug (IND) application in the third quarter of 2019, and, based on regulatory feedback, Xenon expects to initiate a Phase 3 clinical trial thereafter. The company is currently finalizing a pediatric-specific formulation to complete pre-clinical formulation testing with a final drug product expected in the second quarter of 2019.
    • 06 Mar 2019 According to a Xenon Pharmaceuticals media release, In response to Xenon's pre-IND briefing package submission, the FDA indicated that it was acceptable to study XEN496 in infants and children up to 4 years old, and that a single pivotal trial in approximately 20 patients may be considered adequate in order to demonstrate XEN496's efficacy in KCNQ2-EE.
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