Back to search results

Ketogenic Diet for Preventing Epileptic Spasms in Infants

This study is looking at whether a special diet called the ketogenic diet (using KetoVie® formula) can prevent epileptic spasms (a type of seizure) in infants who have certain genetic seizure disorders. Epileptic spasms are common in these conditions and can affect a child's development. Researchers want to see if starting the ketogenic diet early is safe and practical for 10 infants. Success in this study means achieving a state called ketosis (a specific level of a substance called beta-hydroxybutyrate in the body) and how well brain activity (EEG) is monitored. You might be able to join if your baby is under 9 months old, has epilepsy, and your medical team plans to start a ketogenic diet using the KetoVie formula. The current recruitment status is unclear.

Study design
This is a single-center pilot study involving 10 infants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Ketosis will be measured from the start of the diet until 3 months after epileptic spasms are diagnosed (if they occur) or until 12 months of age. EEG compliance will be measured from the start of the diet until the onset of epileptic spasms (if they occur) or until 12 months of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06700811

Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies

Recruiting
PHASE1Ages 0–9InterventionalPrevention
Heather Olson
~10 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Ketogenic diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Achievement of ketosis
Measured over rom ketogenic diet initiation until 3 months after the diagnosis of ES (if it occurs) or until 12 months of age
+1 more outcome measured

Conditions

Developmental and Epileptic Encephalopathies
Epileptic Spasms
Genetic Epilepsy
Neonatal and Infant Epilepsy

Explore related trials

Developmental and Epileptic EncephalopathyEpileptic spasmsGenetic Epilepsy

NCT06700811

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Children's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Heather E Olson, MD, MS
[email protected]
617-355-7970
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Achievement of ketosisrom ketogenic diet initiation until 3 months after the diagnosis of ES (if it occurs) or until 12 months of age

    Proportion of subjects assigned to ketogenic diet who achieve ketosis by 6 weeks and maintain a minimum ratio of 1:1 through 3 months after onset of epileptic spasms (ES) or 12 months of age

  • EEG complianceFrom ketogenic diet initiation until the onset of ES (if it occurs) or until 12 months of age

    Proportion of subjects who complete EEGs every 6 weeks (+/- 2 weeks) until onset of ES or 12 months of age