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:

For healthy volunteers (early stages of the trial):

• Adults aged 18 to 55 years old at the time of signing the consent form
• People who are in good general health, as confirmed by the study doctor based on medical history and health checks
• People who weigh at least 50 kg and have a BMI between 18 and 30

For people with epilepsy (later stage of the trial):

• Adults aged 18 to 70 years old at the time of signing the consent form
• People who have been diagnosed with focal or generalized epilepsy that causes motor (physical movement) seizures, with or without loss of awareness
• People who have at least 4 seizures every 4 weeks while already taking 1 to 3 anti-seizure medicines
• People whose epilepsy medicines and treatments have been stable and unchanged for at least 8 weeks before the study starts, and are expected to stay the same during the study

For everyone:

• Women who could become pregnant must have a negative pregnancy test before starting the trial
• Women who could become pregnant and all male participants must agree to use reliable contraception throughout the study
• People who are able to give their informed consent and follow the study requirements

Who may not be able to join:

For healthy volunteers:

• People who have a history of any significant health condition that has not fully resolved, in the opinion of the study doctor
• People who have taken any prescription or over-the-counter medicines (other than low-dose paracetamol/acetaminophen or ibuprofen), vitamins, or herbal supplements within 7 days (or longer, depending on the medicine) before the study starts

For people with epilepsy:

• People who had a seizure triggered by a specific cause — such as a serious injury, very low or very high blood sugar, cardiac arrest, or lack of oxygen — within the past 3 months

For everyone:

• People who have any uncontrolled medical or mental health condition (such as high blood pressure, diabetes, breathing problems, or depression), as judged by the study doctor
• People with significant abnormal results from physical exams, heart tests (ECG), or blood tests — including certain elevated liver enzyme levels, high bilirubin levels, or an abnormal heart rhythm reading (confirm with trial site)
• People who have had major surgery within 2 months before the study starts
• People who have taken part in another clinical trial or received an experimental drug within 30 days (or longer, depending on the drug) before the screening visit
• People who have received any vaccine within 6 weeks before receiving the study drug
• People who have donated or lost more than 100 mL of blood within 2 months before the study starts, or received a blood transfusion within 3 months before joining
• People who have active liver disease or severe kidney problems
• People who have a known history of substance use disorder
• People with active HIV, active hepatitis B, or active hepatitis C infection
• People who have tested positive for COVID-19 or had COVID-19 symptoms (such as cough, shortness of breath, sore throat, or runny nose) within the past 2 weeks
• People who have a known history of severe allergic reactions to intravenous medicines, biological treatments, or fluids
• People who have any other significant medical or health history that the study doctor believes could put them at risk or affect the study results
• People who have had a prolonged, uncontrolled seizure episode (status epilepticus) within the past 2 years
• People who have had thoughts of suicide within the past 2 years, or who answer "yes" to certain questions on a standard suicide risk assessment (confirm with trial site)
• People who the study doctor believes should not participate for any other reason

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