NCT07287163Enrolling By InvitationPhase 3
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients With Epilepsy
Praxis Precision Medicines37 sites in 6 countries700 target enrollmentStarted: October 27, 2025Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Enrolling By Invitation
- Sponsor
- Praxis Precision Medicines
- Enrollment
- 700
- Locations
- 37
- Primary Endpoint
- To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Open-label 30 mg/day vormatrogine for up to 2 years
Experimental
Participants who meet all eligibility criteria will receive 30 mg of vormatrogine for up to 2 years.
Intervention: vormatrogine (Drug)
Outcomes
Primary Outcomes
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
Time Frame: Up to 2 years
Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (37)
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