A Phase 3 interventional study of vormatrogine in Epilepsy, Tonic-Clonic, Focal Seizure and Primary Generalized Seizure, sponsored by Praxis Precision Medicines. Enrolling by invitation at 36 sites in 6 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Praxis Precision Medicines · Phase 3, Interventional, and Treatment
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy
An open label extension clinical trial to assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.
23 studies on the registry are indexed under Epilepsy, Tonic-Clonic; 3 are open to participants now.
This study's planned enrollment of 700 is above the median of 94 across 20 interventional studies indexed under Epilepsy, Tonic-Clonic.
Browse Epilepsy, Tonic-Clonic studies →Praxis Precision Medicines is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who meet all eligibility criteria will receive 30 mg of vormatrogine for up to 2 years.
Drug: vormatrogine
Once daily oral
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs
Time frame: Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
Change in tympanic temperature in Celsius
Time frame: Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
Change in heart rate in beats per minute
Time frame: Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
Change in blood pressure in mm/Hg
Time frame: Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
Change in respiratory rate in breaths per minute
Time frame: Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
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.
Time frame: Up to 2 years
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
Incidence of clinically significant ECG abnormalities
Time frame: Up to 2 years
Started Oct 2025 (actual). Primary completion is estimated for May 2028, 31 months after the start.
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Praxis Precision Medicines