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Study on Clioquinol for Reducing Seizures in Patients with Drug-Resistant Epilepsy

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of an additional treatment for patients with drug-resistant epilepsy. Epilepsy is a condition that affects the brain and causes repeated seizures. In this study, the medication being tested is called Clioquinol, which is taken as an oral suspension. The purpose of the study is to see if adding Clioquinol to the current treatment can help reduce the frequency and severity of seizures in patients who have not responded well to other treatments.

Participants in the study will receive Clioquinol in addition to their existing epilepsy medications. The study will last for several weeks, during which time the effects of Clioquinol on seizure frequency and severity will be monitored. The study will also assess the safety of Clioquinol by recording any side effects that may occur. Throughout the study, participants will have regular check-ups to ensure their well-being and to evaluate the impact of the treatment on their overall quality of life.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying a history of drug-resistant epilepsy with at least four seizures in a two-week period before the second visit.

    Eligibility criteria also include being between 12 and 35 years old, having failed at least two anti-epileptic drugs (AEDs), and currently using a maximum of three AEDs.

  2. Step 2

    Baseline period

    A baseline period is established to monitor seizure frequency. This period lasts for two weeks but can be extended by one or two weeks if necessary.

    During this time, seizure activity is recorded to provide a comparison for later stages of the trial.

  3. Step 3

    Introduction of clioquinol

    Clioquinol, an oral suspension, is introduced as an add-on treatment. The goal is to assess its effect on reducing seizure frequency and severity.

    The initial dose is administered for two weeks, and the response is evaluated at the third visit.

  4. Step 4

    Dose adjustment

    After the initial two-week period, the dose of clioquinol may be adjusted to a higher level based on the patient's response.

    This phase lasts for an additional four weeks, with the next evaluation occurring at the fifth visit.

  5. Step 5

    Evaluation of response

    The primary endpoint is to determine the percentage of patients who experience a 50% reduction in seizure frequency after two and six weeks of treatment.

    The median percentage reduction in seizure frequency is also assessed at the fifth visit.

  6. Step 6

    Safety and side effects monitoring

    Throughout the trial, safety is monitored through systematic recording of any adverse events.

    Clinical neurological examinations are conducted to identify any potential neuropathy, and both clinical and biochemical adverse events are reported.

  7. Step 7

    Assessment of overall impact

    The severity of seizures is assessed using the NHS3 scale.

    The overall impact of seizures, medication side effects, comorbidities, and quality of life (QoL) is evaluated using the PIES assessment.

Who can join the trial?

5 criteria

  • The patient must have **drug-resistant epilepsy**, which means they have had at least 4 seizures in a 2-week period before the second visit. These seizures should not all happen in just one of the two weeks. This period can be extended by 1 or 2 weeks if needed.
  • The patient must be between **12 and 34 years old** at the time of joining the study.
  • The patient must have tried at least 2 different **anti-epileptic drugs (AEDs)** before joining the study, and these drugs did not work to control the seizures.
  • The patient can be taking a maximum of 3 **anti-epileptic drugs** at the time of joining the study. Other treatments like **Vagus Nerve Stimulation (VNS)** and the **ketogenic diet** are not counted in this limit.
  • The patient must have a clear history of epilepsy with **convulsive seizures**, which are seizures that involve noticeable and countable movements.

Who cannot join the trial?

3 criteria

  • Patients who do not have drug-resistant epilepsy. This means the epilepsy does not respond well to medications.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Clioquinol is being studied as an additional treatment for patients with drug-resistant epilepsy. The goal is to see if adding clioquinol can help reduce the number and severity of seizures in these patients.

What is already known about the treatment

Clioquinol – Clioquinol is administered orally in tablet form. It is currently being explored in clinical trials as an add-on treatment for drug-resistant epilepsy, aiming to reduce seizure frequency and severity. The medication is primarily known for its antimicrobial properties, but in this context, it is being investigated for its potential neurological benefits. Clioquinol works by chelating metal ions, which may help in modulating neural activity and reducing seizures. It is classified as an antimicrobial agent, but its role in epilepsy treatment is still under investigation.

Investigated diseases

Drug-Resistant Epilepsy – This condition occurs when seizures cannot be controlled with standard anti-seizure medications. Patients with drug-resistant epilepsy continue to experience frequent and severe seizures despite trying multiple medications. The seizures can vary in type and intensity, affecting different parts of the brain. Over time, the condition can impact daily life, including cognitive and physical abilities. The unpredictability of seizures can lead to challenges in maintaining a regular routine. Managing this condition often requires exploring alternative treatments or therapies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511388-27-04Protocol codeCLIOKIDAEstimated enrolment20 patientsSponsorUZ Leuven

sourced from the EU Clinical Trials Register and site verification

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