High-Fat diet may stop infant seizures before they start
NCT ID NCT06700811
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This early-phase study tests whether a ketogenic (high-fat) diet can prevent epileptic spasms in infants with genetic epilepsy. Ten babies under 9 months old will receive the diet and be monitored with regular EEGs. The goal is to see if this approach is safe and feasible, potentially protecting brain development by stopping seizures early.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2025
- Expected to finish
-
May 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
0 days to 9 months
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Plan for initiation of ketogenic diet by clinical team for treatment of epilepsy * The clinical team initiating the ketogenic diet agrees that the use of the KetoVie formula is appropriate for the subject, as all study subjects need to receive the same formula * Male or female, age 0 to less than 9 months (including neonates per investigator's judgment) * Epilepsy onset at less than 6 months of age * Abnormal development (any sub score of the Bayley-4 less than 1 standard deviation below the mean) and/or neurologic exam (microcephaly, macrocephaly, strabismus, abnormal vision/CVI, hypotonia, spasticity, dystonia, movement disorder), per investigators judgment * Suspected or confirmed genetic diagnosis as a cause for epilepsy * Weight adequate to complete required study laboratory testing without exceeding maximum allowable blood draws per draw or in a 30 day period per BCH policy Exclusion Criteria: * Epileptic spams prior to enrollment * Tuberous sclerosis complex, trisomy 21 (based on differential response to ES treatment) * Metabolic diagnosis with targeted treatment (including specific indication for ketogenic diet such as glucose transporter disorder, vitamin dependent epilepsies, and others) or exclusion for the ketogenic diet * Ongoing treatment with vigabatrin, ACTH, corticosteroids, topiramate or zonisamide. Other anti-seizure medications are permitted.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Developmental and epileptic encephalopathies are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.