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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

0 Days - 9 Months

Healthy Volunteers

Not accepted

Interventions

• Ketogenic diet — DRUG
  The ketogenic diet formula will be KetoVie®, supplied by Ajinomoto Cambrooke. Ketogenic diet ratio will aim to achieve ketosis, with a minimum level of beta-hydroxybutyrate of 1.0mmol/L. Ratios of ketogenic diet generally range from 1:1 to 4:1. Ratio will increase per standard clinical care for ketogenic diet initiation. For the trial we will aim to reach a maximum of 4:1 by the 6 week follow-up visit, but stopping at a lower ratio if BHB is ≥ 5mmol/L, CO2 ≤ 18 mmol/L, for tolerance, or to meet protein needs. A minimum 1:1 ratio is required to continue in the trial. Ratios higher than 1:1 are often required to obtain ketosis of ideally 2-5mmol/L in infants.

Study Details

Epileptic spasms (ES) are a predominantly infantile seizure type observed frequently in certain genetic disorders. Ketogenic diet (high ratio of fat to carbohydrate/protein) is an established non-medication treatment for difficult to control seizures, including ES. Because ES are associated with worse developmental and cognitive outcomes if not detected or treated quickly and effectively, this trial aims to test the ketogenic diet to prevent ES in this high-risk population. This trial is a single-center pilot study of 10 infants with genetic seizure disorders to establish if the protocol of early ketogenic diet administration and ES evaluation is safe and feasible.

Key Dates

Start date

Aug 11, 2025

Status verified

Jan 2026

Primary completion

Nov 30, 2027

Completion

May 31, 2028

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Ketogenic diet
  KetoVie® 4:1 Formula will be administered by oral feeding or gastrostomy tube as indicated. The duration of the diet will be from the time of enrollment up to 12 months of age or until 3 months after a diagnosis of Epileptic Spasms (range 3-15 months).

Primary Outcome Measure

Achievement of ketosis [ Time Frame: rom ketogenic diet initiation until 3 months after the diagnosis of ES (if it occurs) or until 12 months of age ]

Central Contacts

• Heather E Olson, MD, MS
  617-355-7970
  [email protected]

Locations (1)

Find similar trials in Boston, MA