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Phase 2 Study Evaluating OV329 on Photo‑Induced EEG Response in Adults with Epilepsy

Investigational
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What is this trial about?

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

The study focuses on Epilepsy, a condition that causes repeated seizures, and evaluates the experimental medicine OV329. The aim is to determine whether this oral capsule can change the brain’s reaction to flashing lights that sometimes trigger seizures. The purpose of the study is to assess the effect of the drug on a light‑induced brain response measured with a special recording called an EEG, which tracks electrical activity in the brain.

Participants will first receive a harmless inactive pill (placebo) and then take the study medication, first as a single dose and later as several doses over a short period. During the study, brief sessions with flashing lights will be performed, and the EEG will record any changes in the brain’s activity, a phenomenon known as photosensitivity. The study involves a few visits to the clinic for dosing, monitoring, and the light‑response tests, and it ends after the final series of recordings are completed.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After you join the study, you will have an initial visit where a technician records your brain activity using an electroencephalogram (eeg). this test measures your standardized photosensitivity range (spr), which shows how your brain reacts to flashing lights.

    The results of this test are used as the reference point for all later measurements.

  2. Step 2

    Placebo administration (day 1)

    On the first study day you will take a hard capsule that does not contain the active drug. this is called a placebo.

    The capsule is taken by mouth, and the dose listed for the capsule is 0 mg, meaning it contains no active substance.

    After taking the placebo, another eeg is performed to confirm the baseline spr before any active medication is given.

  3. Step 3

    Single oral dose of ov329

    After the placebo visit, you will receive a single oral dose of ov329 in a hard capsule.

    The capsule is also listed with a dose of 0 mg, indicating the amount of the active ingredient in the capsule as recorded in the study documents.

    You will take the capsule as instructed, and an eeg will be recorded on several days following this dose to see how the spr changes.

  4. Step 4

    Repeated dosing period

    Following the single‑dose assessment, you will continue to take the ov329 capsule once daily for the duration specified by the study team.

    Each day you will swallow the hard capsule by mouth.

    Eeg recordings will be performed on multiple days during this repeated‑dosing phase to track any further changes in the spr.

  5. Step 5

    Final assessment and study completion

    At the end of the repeated‑dosing period, a final eeg will be done to compare the spr with the baseline measurement.

    The study staff will review all your results and complete any remaining safety checks before the trial ends.

Who can join the trial?

3 criteria

  • Be 18 to 65 years old when you sign the consent form, and be either male or female.
  • Have been diagnosed with epilepsy (a condition that causes recurring seizures) and have a medical history of this disorder.
  • Show a repeatable response on a special test called IPS‑induced PPR that scores at least 4 points on a frequency assessment scale during both the initial screening visit and the baseline visit. (The test measures how the brain reacts to a brief light flash, and the score indicates the strength of the response.)

Who cannot join the trial?

4 criteria

  • People who have had seizures that are not caused by epilepsy, such as those due to metabolic problems or “pseudo‑seizures,” cannot join the study. (non‑epileptic seizures are seizure‑like events that have a different cause than epilepsy.)
  • Anyone diagnosed with Classical juvenile myoclonus epilepsy—a type of epilepsy that mainly causes quick, jerky movements (myoclonic seizures) early in the morning—cannot participate.
  • People who are currently using a vagus nerve stimulator (a device that sends mild electrical pulses to a nerve in the neck) or responsive neurostimulation (a system that detects abnormal brain activity and delivers electrical pulses to stop it) are not allowed in the trial.
  • Anyone who is taking or has taken the study drug OV329 as part of another study within the past three months cannot join. (Concomitant therapy means using another medication or treatment at the same time.)
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Investigated drugs

OV329 is an experimental oral medication that is being studied to see if it can affect brain activity in people with epilepsy. In this trial, participants take a hard capsule of OV329, and researchers measure how the drug changes a special EEG response that is triggered by flashing lights. The study looks at the drug’s effect after a single dose and after the participants have taken it repeatedly over time.

What is already known about the treatment

  • OV329

    This medication is supplied as a hard capsule that is taken by mouth. It is an experimental compound that is still being studied and has not yet received regulatory approval. The drug is being tested mainly for the treatment of epilepsy, where it aims to reduce seizure activity by gently adjusting the activity of brain nerve signals. It belongs to the class of investigational antiepileptic agents.

  • Placebo for OV329

    The placebo is an inactive capsule taken orally, designed to look like the active drug but containing no therapeutic ingredient. It is used in clinical trials as a control to compare the effects of OV329. The placebo has no intended medical use and does not produce any pharmacological action. It is classified simply as a trial control substance.

Investigated diseases

Epilepsy - Epilepsy is a brain disorder that causes recurrent seizures. Seizures are brief episodes of abnormal electrical activity that can affect awareness, movement, or sensations. The condition may start at any age and can appear as occasional episodes or become more frequent over time. In some people, seizures become more severe or spread to larger areas of the brain, leading to longer or more complex episodes. The pattern of seizures can change, sometimes increasing in frequency or varying in type as the disease progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-527114-23-00Protocol codeOV329-26-003Estimated enrolment12 patients

sourced from the EU Clinical Trials Register and site verification

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