By InvitationPhase 3

Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

United States700 participantsStarted 2025-10-27

Plain-language summary

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

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

Trial details

NCT IDNCT07287163

SponsorPraxis Precision Medicines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-05-31

View on ClinicalTrials.gov More Epilepsy, Tonic-Clonic trials

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years

To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures

Timeframe: Up to 2 years