PRAX EXT · PRAX-628-323

This is an open-label extension study evaluating the use of vormatrigine as an adjunctive treatment for adult patients diagnosed with focal or generalized onset epilepsy.

Open Label Extension of Vormatrigine as an Adjunctive Therapy in Adult Patients with Focal or Generalized Onset epilepsy.

Sponsor: PRAXIS

Phase: II

Status: Follow-up

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Public study eligibility criteria

Inclusion

  • Participant and caregiver (if applicable), is willing to sign an informed consent document in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, indicating that they understand the purpose of the clinical trial; understands and can perform, complete, and comply with all the procedures and assessments that are required during the clinical trial, including the seizure diary and contraception, and is willing to participate in the clinical trial.
  • Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trial, or participant who has received vormatrigine outside of an eligible clinical trial (such as an expanded access program).
  • Participant who had adequate seizure diary and vormatrigine adherence and had been otherwise adherent to the study procedures in the opinion of the investigator unless deemed unacceptable by sponsor.

Exclusion

  • Participant who withdrew or discontinued treatment from the treatment period of an eligible clinical trial unless deemed acceptable by the sponsor.
  • Participant who plans to enter another interventional investigational study or is on any prohibited medication listed in Table 7.
  • Participant who is pregnant, lactating or planning to become pregnant.
  • Participant who is ineligible for the extension clinical trial in the view of the investigator.