Vormatrigine for Adults with Focal Seizures
This study is testing a medication called vormatrigine to see if it can help adults who have focal seizures (seizures that start in one part of the brain). You might be able to join if you are between 18 and 85 years old, have been diagnosed with focal onset epilepsy, and are currently taking 1 to 3 other seizure medications. The study will compare different doses of vormatrigine (20 mg, 30 mg, or 40 mg daily) to a placebo (a pill with no active medicine) over 12 weeks. The main goal is to see if vormatrigine can reduce how often you have focal seizures. The current status of this study is unclear.
- Study design
- This is a double-blind, randomized study, meaning neither you nor your doctor will know if you are receiving vormatrigine or a placebo. It plans to enroll 300 participants.
- What's involved
- You would take an oral medication once daily for 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07505004
Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures
Active, Not Recruiting
PHASE3Ages 18–85InterventionalTreatmentPraxis Precision Medicines
~300 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:40 mg/day vormatrogine for 12 weeks30 mg/day vormatrogine for 12 weeks20 mg/day vormatrogine for 12 weeksPlacebo
At a glance
Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs
Measured over 12 weeks
Conditions
Where it's being run
7 sites across 5 statesFlorida3
New Jersey1
New York1
North Carolina1
Texas1
Study leadership
- Praxis Precision Medicines · 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?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Has a diagnosis of focal onset epilepsy according to the International League Against Epilepsy Classification of Epilepsy (2017).
Prior to randomization, past evidence by CT or MRI that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.
Participant must attest to be taking stable doses of 1 or up to 3 acceptable ASMs for at least 4 weeks prior to screening and during screening prior to Day 1.
Has at least 4 countable focal onset seizures during the 4 weeks of Observation Period immediately prior to randomization with no more than 21 days seizure free during this period.
Seizure diary must be completed for ≥80% days in the Observation Period.
Exclusion
Participant has had any of the following within the 12-month period preceding trial entry:
Seizures secondary to ongoing infection, neoplasia, demyelinating disease, progressive degenerative disease, metabolic illness deemed progressive, progressive structural lesion or encephalopathy.
Previously documented EEG which shows any pattern not consistent with focal etiology of seizures.
Planned epilepsy surgery during the course of the clinical trial.
History of any of the following:
Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt, as confirmed by C-SSRS.
Has any significant ongoing disease, disorder, laboratory abnormalities, alcohol or drug abuse or dependence, environmental factor, or ongoing or recent history of any psychiatric, medical, or surgical condition.
Participants with a history of malignancy, myeloproliferative or lymphoproliferative disorders within the past 3 years are excluded.
History or presence of uncontrolled cardiac diseases including conduction and structural abnormalities.
Total bilirubin value \>1.5×ULN; an ALT or AST value \>3×ULN.
History of or active HIV infection or positive screening result for: HIV 1 or 2 antibodies. Evidence of active hepatitis B or hepatitis C infection, as determined by relevant screening assessments.
Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene or cell therapy.
Vigabatrin: Use in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin.
Felbamate: If used as a concomitant ASM, patients must be on felbamate for at least 2 years, with a stable dose for 2 months prior to Screening. If a patient received felbamate in the past, it must have been discontinued 2 months prior to screening.
Significant allergic reaction to an ASM(s), including dermatological (e.g. Stevens-Johnson syndrome), hematological, or organ toxicity reactions. Severe reactions do not include simple maculopapular eruption and allergic rhinitis.
Is pregnant or breastfeeding at the time of Screening or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or prior to end of study visit.
Previous exposure to vormatrigine or known hypersensitivity to any component used in the vormatrigine formulation.
What this trial measures
- To evaluate the efficacy of vormatrigine compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs12 weeks
Median percent change in monthly (28 days) focal seizure frequency from the Screening/Observation Period to the Treatment Period for vormatrogine compared to placebo.