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:

• The patient's medical team is already planning to start them on a ketogenic (high-fat, low-carb) diet to help treat their epilepsy
• The patient's medical team agrees that the specific formula used in this study (KetoVie) is appropriate for them
• The patient is male or female, aged from newborn up to (but not including) 9 months old
• The patient's epilepsy started before they were 6 months old
• The patient shows signs of delayed development and/or neurological differences (such as abnormal muscle tone, eye problems, or movement difficulties), as judged by their doctor
• The patient has been diagnosed with a genetic form of epilepsy, confirmed by a gene change that fits their symptoms and family history
• The patient weighs enough to safely have the required blood samples taken without exceeding safe limits for their age and size

Who may not be able to join:

• The patient has experienced a specific type of seizure called epileptic spasms before joining the trial
• The patient has been diagnosed with tuberous sclerosis complex or Down syndrome (trisomy 21)
• The patient has a metabolic condition that has its own specific treatment, or a condition that specifically requires or rules out a ketogenic diet (such as a glucose transporter disorder or certain vitamin-related epilepsies)
• The patient is currently being treated with any of these medications: vigabatrin, ACTH, corticosteroids, topiramate, or zonisamide (other seizure medications are allowed)

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