Ketogenic Diet for New-Onset Absence Epilepsy
Recruiting
Phase 3
Interventional Study
Absence Epilepsy
Ketogenic Dieting
Epilepsy, Absence
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 3 – 12
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Johns Hopkins University · Other
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About This Trial
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 for first-line use (infantile spasms, Glut1 deficiency syndrome) and also anecdotal experience (families choosing to change the child's (or the family' own) diet rather than use anticonvulsant medicati…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 a…
Contacts