Phase 3 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:

• Children aged 2 years old up to (but not including) 18 years old may be considered.
• Children with a diagnosis of Dravet Syndrome (DS), confirmed by a specialist epilepsy group, where seizures began before 13 months of age and no other cause for the condition has been found.
• Children who have had genetic testing showing a specific type of change (pathogenic, likely pathogenic, or uncertain) in a gene called SCN1A — children whose SCN1A test came back completely negative (no variants found) cannot take part.
• Children who have a certain number of specific types of seizures during a 6-week observation period before the trial begins (the trial team will explain what counts and how many are needed).
• Children who have already tried at least 2 treatments for seizures in the past — these can include seizure medicines, a ketogenic diet, or a nerve stimulation device (VNS) — either because the treatment did not control seizures well enough, or because it had to be stopped due to side effects.
• Children who are currently taking at least one seizure medicine on a regular, ongoing basis.
• Children whose seizure medicines, dietary treatments, nerve stimulation device, and any cannabis-based products have remained at a stable dose (except for adjustments based on weight) throughout the baseline period before the trial.

Who may not be able to join:

• Children whose SCN1A gene change is the type known as "gain-of-function" (confirm with trial site).
• Children currently taking certain seizure medicines that work mainly by blocking sodium channels in the brain — this includes medicines such as phenytoin, carbamazepine, oxcarbazepine, lamotrigine, lacosamide, rufinamide, or cenobamate, due to how the trial drug works.
• Children currently using certain brain stimulation devices such as responsive neurostimulation, deep brain stimulation, or transcranial magnetic stimulation — a vagus nerve stimulator (VNS) is an exception and would be permitted.
• Children who have developed a new type of seizure, or had a return of a seizure type that had not occurred for more than 12 months, during the baseline period — or children who have been hospitalised for seizures more than once during the baseline period.

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