Early Phase 1 Epilepsy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 60 years old (inclusive), of any sex.
• People who have been diagnosed with epilepsy involving focal seizures or focal seizures that spread to affect the whole body, as defined by the 2017 international epilepsy classification guidelines.
• People who have a history of seizures lasting 30 seconds or longer, during which awareness is affected.
• People who had at least 16 focal seizures during the 8-week period before joining the trial, with no stretch of 21 days in a row without a seizure.
• People whose brain scan (MRI or CT) or brainwave test (EEG) results from the past 2 years are consistent with focal epilepsy, and do not show a worsening structural brain problem or progressive brain disease.
• People whose epilepsy has not been controlled by at least two appropriate seizure medications tried over a period of 2 years (sometimes called "drug-resistant epilepsy").
• People whose current seizure medications have no known interactions with the study drug (everolimus) and whose doses have been stable for at least 12 weeks before joining.
• People who use a vagus nerve stimulator (VNS) or deep brain stimulator (DBS), provided the device was implanted at least 5 months before screening and its settings have been unchanged for at least 12 weeks.
• People who are willing and able to give written consent to take part in the trial.
• People who, in the treating doctor's judgement, are able to follow the study requirements — including keeping a seizure diary, attending appointments, and taking study medication as directed.

Who may not be able to join:

• People diagnosed with primary generalised epilepsy (where seizures affect the whole brain from the start).
• People who have a history of non-epileptic seizures (such as seizures caused by psychological rather than neurological factors).
• People whose seizures only involve non-motor symptoms (such as sensory changes or altered awareness without any physical movement), with no other seizure types.
• People whose epilepsy has an identifiable and treatable underlying cause, such as a metabolic condition, infection, poisoning, a space-occupying lesion, or a confirmed genetic abnormality.
• People who are unable to reliably count their seizures because seizures occur too frequently, based on the 12 months before starting the study drug.
• People who have experienced clusters of seizures in the 12 months before starting the study drug.
• People who have experienced status epilepticus (a prolonged or repeated seizure emergency) in the 12 months before starting the study drug.
• People who have used mTOR pathway inhibitor medications in the 12 months before starting the study drug.
• People who have had a stroke, brain bleed, or mini-stroke, or who have a worsening brain lesion, in the 6 months before starting the study drug.
• People with severe uncontrolled conditions such as immune system disorders, serious liver or kidney disease, active infection, significant lung problems, or advanced cancer.
• People with severe heart or vascular disease — for example, advanced heart failure (NYHA class III–IV), serious heart rhythm problems (such as long QT syndrome or Brugada syndrome), other significant heart electrical abnormalities, or a heart attack within 3 months before screening.
• People who have had a condition or surgery that might affect how the body absorbs or processes the study drug — such as active stomach ulcer, inflammatory bowel disease, bowel obstruction — or people who have difficulty swallowing.
• People with a medical condition, psychiatric disorder, cognitive impairment, or intellectual disability that, in the investigator's judgement, could increase risk or interfere with participation.
• People whose blood test results show certain abnormalities in liver enzymes, platelet count, white blood cell count, or kidney function (confirm specific thresholds with the trial site).
• People who are pregnant or breastfeeding at the time of screening.
• People with a history of alcohol or substance misuse in the 2 years before starting the study drug.
• People who have taken part in another interventional clinical trial in the 3 months before starting the study drug.
• People with a known allergy or sensitivity to everolimus or any ingredient in the study tablets.
• People currently taking medications that may affect the brain or the way the body processes everolimus.

Important: Always verify eligibility with the trial site directly before applying.