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 between 18 and 60 years old.
• People who have been diagnosed with focal seizures (seizures starting in one part of the brain), or focal seizures that spread to affect the whole brain, according to specific 2017 international diagnostic guidelines.
• People diagnosed with epilepsy that has not responded to at least two different anti-seizure medications over a period of 2 years, whose current medications do not interact with the study drug sirolimus, and whose medication doses have been stable for at least 12 weeks before joining.
• People whose seizures last at least 1 minute and involve some loss or disturbance of awareness or senses.
• People who have had at least 6 focal seizures in the 12 weeks before joining the trial.
• People who have had a brain wave test (EEG) or brain scan (MRI or CT) within the past 2 years that confirms their focal epilepsy diagnosis.
• People who use a vagus nerve stimulator (VNS) or deep brain stimulator (DBS) device, provided the device has been in place for at least 5 months, its settings have been stable for at least 12 weeks before joining, and the settings will remain unchanged throughout the study.
• People who have read and signed an informed consent form agreeing to take part.

Who may not be able to join:

• People diagnosed with generalised epilepsy or epilepsy caused by inherited ion channel gene changes.
• People who have had seizures that are psychological rather than electrical in origin (psychogenic non-epileptic seizures) within the past 12 months.
• People whose epilepsy has a treatable underlying cause, such as a metabolic problem, poisoning, infection, a growth in the brain, or a identified genetic condition.
• People who only experience focal seizures without any movement symptoms, as defined by the 2017 international epilepsy guidelines.
• People who have experienced seizure clusters (multiple seizures in a short period) within the past 12 months.
• People who have had a prolonged full-body convulsive seizure (tonic-clonic status epilepticus) within the past 12 months.
• People who have had a stroke, brain bleed, or mini-stroke within the past 6 months, or who have a progressive problem developing inside the skull.
• People with severe uncontrolled health conditions such as immune system disorders, serious liver or kidney disease, active infections, or advanced cancer.
• People with serious heart or blood vessel disease, including certain heart rhythm problems (such as Long QT syndrome, Brugada syndrome, or significant electrical conduction issues in the heart), or those who have had a heart attack within the past 3 months.
• People with a history of conditions or surgeries that a doctor believes could affect how the study drug is absorbed or processed by the body, such as active stomach ulcers, inflammatory bowel conditions, bowel blockages, or difficulty swallowing.
• People with any health condition, mental health issue, cognitive difficulty, or intellectual disability that a doctor believes could increase risk or affect the person's ability to participate.
• People who have had a severe allergic reaction to sirolimus or any of its ingredients, or who are known to be sensitive to it.
• People whose blood test results fall outside acceptable ranges, specifically relating to liver enzyme levels, platelet count, white blood cell count, or kidney filtering function (confirm with trial site for exact values).
• People who are currently pregnant, giving birth, or breastfeeding.
• People who have misused alcohol or drugs within the 2 years before starting the study medication.
• People who have taken part in another clinical trial within the past 3 months.

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