Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

Phase 3Enrolling By InvitationNCT07287163

Praxis Precision Medicines700 enrolled

Overview

Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy

An open label extension clinical trial to assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

700

Conditions

Epilepsy, Tonic-Clonic Focal Seizure Primary Generalized Seizure

Interventions

vormatrogineDRUG

Once daily oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trials, 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 Criteria: * 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 * 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

Locations (20)

Praxis Research Site

Miami Lakes, Florida, United States

Praxis Research Site

Naples, Florida, United States