Status:
RECRUITING
Ketogenic Diet for New-Onset Absence Epilepsy
Lead Sponsor:
Johns Hopkins University
Conditions:
Absence Epilepsy
Ketogenic Dieting
Eligibility:
All Genders
3-12 years
Phase:
PHASE3
Brief Summary
The ketogenic diet is a medical therapy for epilepsy that is used nearly predominantly for refractory epilepsy (after 2-3 drugs have been tried and failed). However, there is both published evidence f...
Detailed Description
The ketogenic diet has been in continuous use since 1921 for children and adult with medically-refractory epilepsy. One of the major unanswered questions is whether it would be as effective for childr...
Eligibility Criteria
Inclusion
- Children ages 3-12 years at seizure onset with classic childhood absence epilepsy clinically.
- Normal intellect or mild disability
- EEG with confirmed 3/second spike-wave discharges, usually with hyperventilation
- Daily reported absence seizures.
- Generalized convulsions allowed
Exclusion
- Previous treatment with any anticonvulsant drug
- Previous use of a ketogenic dietary therapy for epilepsy or any other condition
- Glut1 deficiency syndrome
- Metabolic disorder known that would preclude dietary therapy
- Dietary restrictions for which a high fat, low carbohydrate diet would be precluded.
- Prior history of epilepsy (febrile seizures allowed)
- Unwilling to consent to study procedures or return for visits
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04274179
Start Date
August 10 2020
End Date
May 1 2026
Last Update
August 12 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287