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:

• The patient, or their legal guardian, is able to give formal consent to take part in the study.
• The patient, or their legal guardian, is considered by the study team to be able to follow the study requirements.
• The patient is between 6 months and 21 years of age at the time of consent.
• The patient has a confirmed harmful or likely harmful change in the SCN1A gene, shown by genetic testing.
• The patient developed normally before their first seizure occurred.
• The patient had their first epileptic seizure between 3 and 15 months of age.
• The patient is currently taking at least one of the following seizure medications: brivaracetam, clobazam, cannabidiol, fenfluramine, levetiracetam, sodium valproate, stiripentol, or topiramate.

Who may not be able to join:

• The patient has a type of SCN1A gene change (called a copy number variation) that also affects surrounding genes, including a small deletion of the SCN1A gene.
• The patient has an SCN1A gene change on both copies of the gene (one from each parent).
• The patient has a known or suspected harmful change in any other gene linked to epilepsy, aside from SCN1A.
• The patient has another genetic change or additional health condition that is likely to alter the typical features of Dravet syndrome.
• The patient has a specific type of SCN1A gene change known as a "gain-of-function" mutation (confirmed by laboratory testing), including the specific variant known as p.Thr226Met.
• The patient's medical records show signs of abnormal brain or developmental development before seizures began.
• The patient has been completely free of seizures for one year or more before the consent date.
• The patient has ever taken any of the following seizure medications for six or more consecutive weeks, as these are known to worsen Dravet syndrome: carbamazepine, eslicarbazepine, lacosamide, lamotrigine, oxcarbazepine, phenytoin (taken regularly by mouth), tiagabine, or vigabatrin.
• The patient has previously received advanced therapies such as antisense oligonucleotides, gene therapy, or cell therapy.
• The patient has a physical abnormality seen on a brain scan (MRI or CT) that the lead study doctor considers to be a source of seizures.

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