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NCT07287163

Clinical Trial of Vormatrigine in Adult Patients With Epilepsy

Enrolling by Invitation
PHASE3Ages 18–85InterventionalTreatment
Praxis Precision Medicines
~700 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:vormatrogine

At a glance

Recruiting sites
0 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
Measured over Up to 2 years
+6 more outcomes measured

Conditions

Epilepsy, Tonic-Clonic
Focal Seizure
Primary Generalized Seizure

Explore related trials

Generalized SeizurePartial SeizureSeizure DisorderTonic-Clonic Seizure

Where it's being run

36 sites across 17 states
Italy6
Spain5
New York4
Poland4
Florida3
Texas2
Germany2
Louisiana1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Praxis Precision Medicines

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizuresUp to 2 years

    Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs

  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizuresUp to 2 years

    Change in tympanic temperature in Celsius

  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizuresUp to 2 years

    Change in heart rate in beats per minute

  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizuresUp to 2 years

    Change in blood pressure in mm/Hg

  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizuresUp to 2 years

    Change in respiratory rate in breaths per minute

  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizuresUp to 2 years

    The principal investigator (PI) or sub investigator will review the laboratory report and document this review. Any clinically significant adverse changes occurring during the clinical trial will be documented as adverse events.

  • To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizuresUp to 2 years

    Incidence of clinically significant ECG abnormalities