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A study to evaluate the effectiveness and safety of vormatrigine in adults with focal epilepsy who are taking one to three anti-seizure medications.

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the effectiveness and safety of the drug PRAX-628, which contains the active substance vormatrigine, in adults living with Focal Epilepsy. This condition is a type of seizure disorder where electrical disturbances in the brain are limited to one specific area. The participants in this study are currently using one to three anti-seizure medications, which are drugs used to reduce the occurrence of seizures.

During the study, participants will be assigned to receive either PRAX-628 or a placebo. This is done through a process called randomization, where groups are chosen by chance to ensure the results are fair. The study is also double-blind, meaning that neither the participants nor the researchers know which treatment is being given until the study is over. The process involves an initial observation period to record the current number of seizures, followed by a treatment period where the effects of the medication are studied.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Observation period
The observation period is the initial phase where the current frequency of focal seizures (seizures that start in one specific area of the brain) is recorded to establish a baseline for comparison.
Step 2
Treatment period
During the treatment period, an oral tablet is taken. This is either the test medication, vormatrigine, or a placebo, which is an inactive substance that looks like the medicine but contains no active ingredients.
The vormatrigine is administered in different possible doses of 20 mg, 30 mg, or 40 mg.

Who can join the trial?

10 criteria

The person joining the study and their caregiver, if they have one, must agree to sign a document called informed consent, which means they understand the study's purpose and agree to follow all the rules, including keeping a seizure diary (a daily log used to record when seizures happen).
Participants must be willing to use specific contraception methods (ways to prevent pregnancy) as required by the study.
The person must be at least 18 years old and no older than 85 years old.
The person must have been diagnosed with focal onset epilepsy, which is a type of seizure disorder that starts in one specific area of the brain.
The person must have had previous brain scans, such as a CT (a type of X-ray that shows body structures) or an MRI (a detailed picture of the inside of the body using magnets), that show their epilepsy is not caused by a disease that gets worse over time.
The person must have been taking a steady amount of one to three ASMs (anti-seizure medications, which are drugs used to prevent or reduce seizures) for at least 4 weeks before the study begins.
The ASM dose must not be higher than the maximum amount recommended by local medical guidelines.
The person must have experienced a specific number of focal onset seizures (seizures starting in one part of the brain) during a set observation period before the study starts.
The person must have had no more than a specific number of seizure-free days (days without any seizures) during that same observation period.
The person must have successfully filled out their seizure diary for at least 80% of the days during the observation period.

Who cannot join the trial?

22 criteria

You have had pseudo or psychogenic seizures (seizures that are not caused by electrical problems in the brain) within the last 12 months.
You have had cluster seizures (seizures that happen so close together that they cannot be easily counted) in the last 12 months.
You have had an episode of convulsive status epilepticus (a medical emergency where a seizure lasts too long or multiple seizures happen without regaining consciousness) that required you to be in the hospital and use a breathing tube.
Your seizures were caused by using illegal drugs or alcohol in the last 12 months.
Your liver function tests show levels of bilirubin (a yellow substance produced by the liver), ALT, or AST (enzymes that show liver health) that are higher than the normal range, unless you have a specific harmless condition called Gilbert's syndrome.
You have an active HIV infection or have tested positive for HIV antibodies.
You have active hepatitis B or hepatitis C (infections that cause liver inflammation).
You have taken any other experimental drugs, medical devices, or gene or cell therapies (treatments that change your genetic material) within the last 30 days or a specific timeframe based on how fast the drug leaves your body.
You have used the medication vigabatrin in the last 5 years without having your visual fields (your peripheral or side vision) tested and proven stable twice in the last 12 months.
You use felbamate (an anti-seizure medication) but have not been on a stable dose for at least 2 months, or you used it in the past but did not stop it at least 2 months before starting this study.
You are taking any medications that are listed as prohibited by the study rules.
You have had a severe allergic reaction to an anti-seizure medication (ASM), such as reactions affecting your skin, blood, or organs.
You are pregnant, breastfeeding, planning to become pregnant, or have had a positive pregnancy test.
You have previously used vormatrigine or are allergic to any of its ingredients.
Your seizures are caused by an ongoing infection, a tumor, demyelinating disease (damage to the protective coating of nerves), a progressive brain disease, or a structural problem in the brain seen on a CT or MRI scan.
A previous EEG (a test that records brain electrical activity) shows a pattern that does not match focal epilepsy (seizures that start in one specific area of the brain).
You are planning to have epilepsy surgery during the study.
You have had brain surgery, radiosurgery (a type of radiation treatment), or a neurostimulator (a device placed in the body to control brain activity) within a specific recent timeframe.
You have had a plan or intent for suicide in the last 6 months, a suicide attempt in the last 2 years, or more than one suicide attempt in your lifetime.
You have any other ongoing medical, psychiatric, or surgical condition that the doctors believe could make the study unsafe for you or interfere with the results.
You have had malignancy (cancer) or certain blood disorders in the past 3 years, unless it was a specific type of skin cancer that was completely removed or a cancer that is considered cured.
You have uncontrolled cardiac diseases (heart problems), such as issues with the heart's electrical rhythm or structure, including a family history of sudden death or specific heart syndromes.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera Universitaria Di Cagliari
Monserrato, Italy
Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland
Responsive
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate
Chieti, Italy

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Investigated drugs

Vormatrigine is an experimental medication taken by mouth in tablet form. It is being studied to see how well it can help reduce the number of focal seizures in adults who are already using other anti-seizure medicines.

VORMATRIGINE

What is already known about the treatment

Vormatrigine - This medication is taken as a tablet by mouth and is currently being studied in clinical trials to see how well it works. It is being developed to help adults who experience focal seizures, which are specific types of seizures that start in one part of the brain. At a molecular level, it works by calming down overactive nerve cells to prevent them from sending the electrical signals that cause a seizure. It is classified as an anti-seizure medication.

Investigated diseases

Focal Epilepsy - This is a type of neurological disorder characterized by recurring seizures that originate in a specific area of the brain. These seizures involve a limited group of nerve cells rather than spreading throughout the entire brain at once. As the condition progresses, the frequency and intensity of these seizure events may change over time. The episodes can manifest with various symptoms depending on which part of the brain is affected. This disorder is typically a chronic condition that requires ongoing management.