Early Phase 1 Epilepsy Trial, Recruiting

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

Who might be able to join this trial:

• Children and teenagers aged 2 to 18 years who have been diagnosed with Dravet syndrome caused by a change (mutation) in the SCN1A gene, where seizures started before 12 months of age.
• Participants must have had at least 6 seizures in the 12 weeks before joining, and at least 2 seizures in the 4 weeks before joining (some participants in a later stage of the trial also need at least 4 seizures in the 4 weeks after signing consent).
• The SCN1A gene change must be confirmed by testing as causing or likely causing Dravet syndrome.
• Must have already tried at least one epilepsy treatment — such as seizure medication, a ketogenic diet, or a vagus nerve stimulator — but seizures were not well controlled, or the treatment had to be stopped due to side effects.
• Must currently be taking at least one anti-seizure medication, at a stable dose for at least 4 weeks before the study starts.
• All epilepsy treatments must have been stable for at least 4 weeks before joining and are expected to stay stable throughout the study (dose changes based on body weight are allowed).
• The child's parent or guardian must be willing to participate and sign a consent form.

Who may not be able to join:

• Children who have other known gene mutations causing Dravet syndrome, or who have a specific type of SCN1A mutation known as a "gain-of-function" mutation (a long list of specific mutations apply — confirm with trial site).
• Children currently taking certain seizure medications that work mainly by blocking sodium channels, such as carbamazepine, oxcarbazepine, lamotrigine, lacosamide, or rufinamide.
• Children currently receiving certain types of brain stimulation therapy (such as deep brain stimulation), though vagus nerve stimulation is allowed.
• Children who have received gene therapy or cell therapy within the past year.
• Children who have received any vaccine within the past 12 weeks.
• Children with certain abnormal liver or kidney blood test results (confirm with trial site).
• Children with another serious uncontrolled illness in addition to Dravet syndrome.
• Children with a history of autoimmune disease, or an uncontrolled infection in the week before joining.
• Children with a history of brain or spinal cord disease (other than epilepsy, Dravet syndrome, or injury), or a history of bacterial meningitis.
• Children with an abnormally shaped spine or any condition that might affect the normal flow of fluid around the brain and spinal cord, or who have a shunt in that fluid system.
• Anyone who is pregnant or breastfeeding.
• Children with any other significant health condition that the trial doctor believes could put them at risk or affect their ability to take part (confirm with trial site).

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