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:

• A parent or caregiver must be willing and able to give permission for the child to take part, and if the child is old enough to understand, they should also agree to participate.
• The participant and their parent or caregiver must be willing and able to follow all the requirements of the study.
• The participant must be between 0 and 18 years old at the time of joining.
• The participant must have a confirmed harmful or likely harmful change (mutation) in the SCN1A gene, shown through genetic testing.
• The participant must have developed normally before their first seizure, based on standard developmental guidelines.
• The participant's first seizure must have started between 3 and 5 months of age, and must have been a specific type (such as a prolonged seizure, a tonic-clonic seizure, or status epilepticus — confirm exact seizure types with trial site).
• The participant must have been assessed by a children's neurologist and diagnosed with Dravet Syndrome (DS).

Who may not be able to join:

• The participant has a large section of the SCN1A gene missing (called a copy number variant or microdeletion) that also affects other nearby genes.
• The participant has an SCN1A mutation on both copies of the gene (one from each parent).
• The participant has a known or suspected harmful mutation in another gene linked to seizures, besides SCN1A.
• The participant has a confirmed mutation in another gene (not SCN1A) that is known to make seizures more severe.
• The participant has a specific type of SCN1A mutation that causes the gene to become overactive (called a gain-of-function mutation), including a specific one known as p.Thr226Met.
• The participant had noticeable developmental delays or problems before their first seizure, as reported by a doctor.
• The participant has a known structural problem in the brain (found on an MRI or CT scan) that does not fit the expected pattern for Dravet Syndrome, in the opinion of the lead doctor.
• The participant has any metal implants in their body.
• The participant has a baclofen pump (a device implanted in the body to deliver medication).
• The participant or their parent/caregiver is unwilling or unable to provide written consent (and/or the child's agreement, where appropriate).

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