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.

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.

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.

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.

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.

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.

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.