NCT04274179 Ketogenic Diet for New-Onset Absence Epilepsy
| NCT ID | NCT04274179 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Johns Hopkins University |
| Condition | Absence Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-08-10 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2020-08-10 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 medications). Childhood absence epilepsy (refractory) has been published as being responsive to ketogenic diet therapy by the investigators' group previously. This is a small, prospective, 3 month trial to assess if using a modified Atkins diet is a feasible and effective option for new-onset childhood absence epilepsy. The investigators will compare to a group of children in which the parents have declined and chose to start anticonvulsant medications.
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 allowed Exclusion Criteria: * 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
Contact & Investigator
Eric H Kossoff, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT04274179 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 12 Years, studying Absence Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04274179 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT04274179 currently recruiting?
Yes, NCT04274179 is actively recruiting participants. Contact the research team at ekossoff@jhmi.edu for enrollment information.
Where is the NCT04274179 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT04274179 clinical trial?
NCT04274179 is sponsored by Johns Hopkins University. The principal investigator is Eric H Kossoff, MD at Johns Hopkins University. The trial plans to enroll 40 participants.
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