Phase 3 Rare Disease 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:

• You are between 1 and 18 years old
• You have been officially diagnosed with epilepsy that has not responded well to treatment (known as refractory epilepsy), confirmed using recognised medical guidelines
• You have had at least 4 seizures during a 4-week observation period before the trial starts, and these seizures did not all happen within the same week
• All your epilepsy medications or other treatments have been at the same dose for at least one month before screening, and you and your doctor are willing to keep them the same throughout the trial
• You (or your parent or legal guardian) are able to give informed consent to take part
• There is a caregiver who is regularly available and able to report on your condition throughout the trial

Who may not be able to join:

• You have a known or suspected allergy or sensitivity to cannabinoids (cannabis-based substances) or any ingredients in the trial medication, which contains cannabis extract and refined peanut oil (confirm with trial site if you have a peanut allergy)
• You have a known history of, or current signs of, significant liver problems, including abnormal liver test results above certain levels
• You are pregnant, breastfeeding, or planning to become pregnant during the trial or within 3 months of finishing treatment
• You have a heart condition, including structural heart problems, heart failure, reduced blood supply to the heart, Brugada syndrome, long-QT syndrome, or irregular heart rhythms
• You have glaucoma (a condition affecting pressure in the eyes)
• You are currently being assessed to see whether you might be suitable for epilepsy surgery
• You had a vagal nerve stimulator (a device used to reduce seizures) fitted within the last 3 months and are not willing to wait until its settings are stable before joining
• You started a ketogenic diet (a special high-fat, low-carbohydrate diet sometimes used for epilepsy) within the last 3 months and are not willing to wait until the diet is stable before joining
• You have another ongoing medical condition, separate from your epilepsy, that could significantly affect your ability to take part (your doctor will help decide this)
• You have used recreational or medicinal cannabis, or any cannabis-based medication, within the last 3 months and are not willing to stop using it for the duration of the study
• You are planning to have a procedure under general anaesthetic that would affect the observation period before the trial, or any major surgery during the trial
• You are not expected to be able to have blood samples taken due to significant anxiety or resistance
• You have been taking a specific anti-seizure medication called clobazam at a dose higher than 0.5 mg per kg of body weight per day during the last month

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