Actively Recruiting
A Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures
Led by Praxis Precision Medicines · Updated on 2026-04-01
300
Participants Needed
7
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of vormatrigine in adults with focal seizures. This Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial aims to compare different doses of vormatrigine with a placebo in adults who are currently taking one to three antiseizure medications (ASMs). The study focuses on participants diagnosed with focal onset epilepsy and excludes those with progressive causes of epilepsy or other complicating conditions. Participants will be randomly assigned at the start of the study to receive one of three doses of vormatrigine (40 mg, 30 mg, or 20 mg) or a placebo, taken once daily by mouth for 12 weeks. The trial includes multiple study arms to compare these dose groups directly against placebo under blinded conditions to ensure unbiased results. During the 12-week treatment period, participants will be monitored for their focal seizure frequency using seizure diaries and other assessments. Safety and tolerability will also be evaluated throughout the study. The main outcome will measure the change in seizure frequency compared to placebo during the 12 weeks. Participants will attend scheduled study visits for ongoing assessments, including adherence, safety monitoring, and seizure tracking. The study is expected to conclude by May 2027.
CONDITIONS
Brief Title
Double-blind, Randomized Clinical Trial Evaluating the Efficacy and Safety of Vormatrigine in Adults With Focal Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of focal onset epilepsy according to International League Against Epilepsy Classification (2017)
- Past CT or MRI evidence ruling out progressive cause of epilepsy
- Taking stable doses of 1 to 3 acceptable antiseizure medications for at least 4 weeks before screening
- At least 4 countable focal seizures in the 4 weeks before randomization with no more than 21 seizure-free days
- Seizure diary completed for at least 80% of days during the observation period
You will not qualify if you...
- History in past 12 months of pseudo or psychogenic seizures, uncountable cluster seizures, convulsive status epilepticus requiring hospitalization, or seizures due to drug/alcohol use
- Seizures caused by infection, neoplasia, demyelinating or progressive degenerative disease, metabolic illness, progressive structural lesion, or encephalopathy
- EEG patterns inconsistent with focal seizures
- Planned epilepsy surgery during the trial
- Neurosurgery for seizures less than 1 year ago or radiosurgery less than 2 years ago
- Neurostimulator implanted less than 1 year before screening or unstable settings
- Active suicidal plan or multiple suicide attempts per C-SSRS
- Significant ongoing medical, psychiatric, or surgical conditions
- History of malignancy or certain blood disorders in past 3 years
- Uncontrolled cardiac diseases
- Elevated liver function tests beyond specified limits
- Active HIV, hepatitis B or C infection
- Recent use of other investigational drugs or gene/cell therapies
- Use of vigabatrin in last 5 years without stable visual field testing
- Felbamate use not stable or discontinued less than 2 months prior
- Severe allergic reactions to antiseizure medications
- Pregnant, breastfeeding, or planning pregnancy during the trial
- Previous exposure or hypersensitivity to vormatrigine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take once daily oral doses of vormatrigine or placebo for 12 weeks to evaluate efficacy and safety in controlling focal seizures.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 7 locations
1
Praxis Research Site
Miami, Florida, United States, 33133
Actively Recruiting
2
Praxis Research Site
Miami Lakes, Florida, United States, 33016
Actively Recruiting
3
Praxis Research Site
Naples, Florida, United States, 34116
Not Yet Recruiting
4
Praxis Research Site
Marlboro, New Jersey, United States, 07746
Actively Recruiting
5
Praxis Research Site
Niagara Falls, New York, United States, 14304
Actively Recruiting
6
Praxis Research Site
Raleigh, North Carolina, United States, 27607
Actively Recruiting
7
Praxis Research Site
Houston, Texas, United States, 77058
Actively Recruiting
Research Team
S
Senior Medical Director Clinical Development
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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