Actively Recruiting
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
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of vormatrigine in adults with focal seizures (POWER2)
CONDITIONS
Official 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 the International League Against Epilepsy Classification (2017)
- Brain CT or MRI ruling out progressive causes of epilepsy prior to randomization
- Taking stable doses of 1 to 3 acceptable anti-seizure medications for at least 4 weeks before screening
- At least 4 countable focal seizures during 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 within 12 months of pseudo or psychogenic seizures, cluster seizures that cannot be counted, convulsive status epilepticus requiring hospitalization and intubation, or seizures due to illicit drug or alcohol use
- Seizures caused by ongoing infection, neoplasia, demyelinating disease, progressive degenerative disease, metabolic illness, progressive structural lesion, or encephalopathy
- EEG showing patterns inconsistent with focal seizures
- Planned epilepsy surgery during the trial
- Neurosurgery for seizures less than 1 year before enrollment
- Radiosurgery less than 2 years before enrollment
- Neurostimulator placed less than 1 year before screening or unstable settings if placed more than 1 year prior
- Active suicidal plan or intent in past 6 months, or history of suicide attempt in past 2 years or multiple lifetime attempts
- Significant ongoing disease, laboratory abnormalities, substance abuse, psychiatric, medical, or surgical conditions
- History of malignancy, myeloproliferative or lymphoproliferative disorders within past 3 years
- Uncontrolled cardiac diseases including conduction and structural abnormalities
- Elevated total bilirubin (>1.5 times upper limit normal), ALT or AST (>3 times upper limit normal)
- HIV infection or positive HIV screening, active hepatitis B or C infection
- Use of any experimental drug, device, gene or cell therapy within 30 days or 5 half-lives prior to screening
- Use of vigabatrin in last 5 years without stable visual field testing
- Felbamate use must be stable for at least 2 years or discontinued 2 months prior to screening
- Significant allergic reaction to an anti-seizure medication including severe dermatological, hematological, or organ toxicity reactions
- Pregnant, breastfeeding, positive pregnancy test at screening, or planning pregnancy during the study
- Previous exposure or known hypersensitivity to vormatrigine or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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