Actively Recruiting
Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies
Led by Heather Olson · Updated on 2026-02-02
10
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
Sponsors
H
Heather Olson
Lead Sponsor
B
Boston Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ketogenic Diet for Prevention of Epileptic Spasms in Infantile Onset Genetic Epilepsies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Plan for initiation of ketogenic diet by clinical team for treatment of epilepsy
- The clinical team agrees that the KetoVie formula is appropriate for the subject
- 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 and/or abnormal neurologic exam per investigator's judgment
- Genetic epilepsy diagnosis with pathogenic or likely pathogenic variant(s) consistent with phenotype and inheritance
- Weight adequate to complete study laboratory testing without exceeding blood draw limits per BCH policy
You will not qualify if you...
- Epileptic spasms prior to enrollment
- Diagnosis of tuberous sclerosis complex or trisomy 21
- Metabolic diagnosis with targeted treatment or exclusion for ketogenic diet
- Ongoing treatment with vigabatrin, ACTH, corticosteroids, topiramate, or zonisamide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
H
Heather E Olson, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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