NCT04274179RecruitingPhase 3
Ketogenic Diet for New-Onset Absence Epilepsy
A Prospective, Case-control Evaluation of Ketogenic Dietary Therapy for New-onset Childhood Absence Epilepsy
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 14 Feb 2020
- Start date
- 10 Aug 2020
- Primary completion date
- 1 May 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- Epilepsy
- NCT number
- NCT04274179
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 40
- From 10 Aug 2020 to the primary completion date, 1 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with any anticonvulsant drug
- Previous use of a ketogenic dietary therapy for epilepsy or any other condition
- Prior history of epilepsy (febrile seizures allowed)
Other illness
- Glut1 deficiency syndrome
- Metabolic disorder known that would preclude dietary therapy
Other
- Dietary restrictions for which a high fat, low carbohydrate diet would be precluded.
- Unwilling to consent to study procedures or return for visits
Who the study is looking for
- 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
Age in the registry: 3 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.