Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

Praxis Precision Medicines

Status and phase

Invitation-only

Phase 3

Conditions

Primary Generalized Seizure

Focal Seizure

Epilepsy, Tonic-Clonic

Treatments

Drug: vormatrogine

Study type

Interventional

Funder types

Industry

Identifiers

NCT07287163

PRAX-628-323

Details and patient eligibility

About

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

Full 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.

Enrollment

700 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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