Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

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

Status

Enrolling by invitation

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07287163

Enrollment

700

Registered

2025-12-17

Start date

2025-10-27

Completion date

2028-12-31

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Tonic-Clonic, Focal Seizure, Primary Generalized Seizure

Keywords

epilepsy, tonic-clonic, seizure, focal

Brief summary

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

Detailed description

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

Interventions

DRUGvormatrogine

Once daily oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures	Up to 2 years	Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs

Countries

Brazil, Germany, Italy, Poland, Spain, United States

Contacts

STUDY_DIRECTORMedical Director

Praxis Precision Medicines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026