Phase 2 Epilepsy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- The child must be between 2 and 12 years old at the time of signing up for the study.
- The child must have at least one parent or caregiver who is 18 years or older, is willing to give written consent, and can attend all study appointments.
- The child must have been formally diagnosed with Dravet Syndrome (DS) according to recognised international medical guidelines.
- The child must have a confirmed genetic change (variant) in a specific gene called SCN1A that is known or likely to cause their condition.
- The child must currently be taking at least one seizure medication at a steady, unchanged dose for at least 4 weeks before joining the study.
- Any other epilepsy treatments (such as a special diet or a nerve stimulation device), other medications, supplements, or nutritional support must have been at a stable level for at least 4 weeks before joining; if a nerve stimulation device was implanted, this must have happened at least 6 months before joining.
- The child must experience a required number of specific types of seizures during the initial screening period of the study (confirm with trial site for exact number).
Who may not be able to join:
- The child has a known brain or spinal condition that could make a spinal fluid collection procedure (a lumbar puncture) unsafe or difficult.
- The child has a confirmed genetic change in a different gene (other than SCN1A) that is known to cause epilepsy.
- The child has previously received, or is currently taking part in a trial for, a gene therapy or a similar type of drug called an antisense oligonucleotide (ASO) for Dravet Syndrome.
- The child has taken part in a trial of any other experimental drug, biological treatment, or medical device within the past 30 days (or longer, depending on the specific treatment involved).
- The child is currently taking a seizure medication that works mainly by blocking sodium channels in the brain as a regular ongoing treatment (confirm with trial site for specific medications).
- The child has previously had certain brain surgeries, such as an operation to cut connections between the two sides of the brain, deep brain stimulation device implantation, or any other brain surgery aimed at reducing seizures.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: (844) 867-4309
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Parts 1 and 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs; Number of Participants With Clinically Significant Change From Baseline in Safety Laboratory Values; Parts 1 and 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs; Parts 1 and 2: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG); Parts 1 and 2: Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings; Parts 1 and 2: Number of Participants w...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.