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Ketogenic Diet for New-Onset Absence Epilepsy

A Prospective, Case-control Evaluation of Ketogenic Dietary Therapy for New-onset Childhood Absence Epilepsy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04274179
Enrollment
40
Registered
2020-02-18
Start date
2020-08-10
Completion date
2028-05-01
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Absence Epilepsy, Epilepsy, Absence, Ketogenic Dieting

Keywords

ketogenic, diet, absence

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.

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 children with new-onset epilepsy. Although logically, this would be the case, it remains to be shown in clinical trials. Additionally, it is much easier to take a medication than to change dietary habits and there is doubt whether families would truly wish to try dietary therapy first (or stay on dietary therapy if not effective for a 6 month trial period). There is limited published evidence supporting the use of the ketogenic diet as a first-line therapy for infantile spasms, myoclonic astatic epilepsy, and in some situations where a family member had success and the family wishes to start it first. However, these are relatively rare conditions. The emergence of the modified Atkins diet as an outpatient, quickly-initiated, non-fasting approach since 2003 has changed the concept of dietary therapy towards a much less restrictive, potentially emergent therapy. In this way, using dietary therapy could potentially be started before medications for a willing family. The use of dietary therapy (including the modified Atkins diet) for childhood absence epilepsy goes back decades, but was recently profiled in a review article from the investigators' group. In this publication, 17 studies were identified, and 69% of 133 children with refractory childhood absence epilepsy had a \>50% seizure reduction and 34% were seizure-free. At the investigators' center, 21 children as of 2011 had been treated with dietary therapy with 19% seizure-freedom. The question of whether results would be similar (or better) for children with new-onset absence epilepsy was unanswered. The standard treatments for childhood absence epilepsy (ethosuximide, valproate, lamotrigine) are effective in \ 50% of children by 16-20 weeks. However, side effects exist and include stomach upset, inattention, mood disturbance, rash, liver function test abnormalities, and fatigue. Families at times do ask about avoiding treatment completely, especially as this epilepsy usually resolves in puberty and convulsions only occur in 20% (most children have brief staring spells only). In addition, families do also ask about "nonpharmacologic" treatment, but to date the investigators have not recommended it due to lack of data. This study will have 20 children in each arm (diet and drug) with ability to crossover. Parents with a child with new-onset absence epilepsy will choose between the two therapies. Visits will be at baseline, 1 month and 3 months. EEG, labs and clinic visits will be paid by the parent's insurance (not free).

Interventions

OTHERModified Atkins Diet

Low carb (20g/day), high fat, moderate protein diet. Started as an outpatient in clinic.

DRUGAbsence epilepsy medications

At neurologist's discretion. \*OF NOTE\< THIS ARM IS COMPLETED

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Two arms (diet and drugs) with ability to cross-over at 1 or 3 months.

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in seizure frequencyAt 1 and 3 months post treatmentParental report of seizure frequency.

Secondary

MeasureTime frameDescription
Tolerability of diet therapy as assessed by restrictiveness of the diet therapyAt 3 monthsDiet therapy restrictiveness will be assessed with an open ended questionnaire that asks "how hard has it been for the child?". Completely subjective with no scale or scoring.
Duration of diet therapyUp to 3 months post treatmentDuration of diet therapy in months.
Tolerability of diet therapy as assessed by change in urinary ketonesAt 1 and 3 months post treatmentUrinary ketones in mg/dl will be measured (80-160mg/dl is considered large ketosis).
EEG changes (normalization of the baseline spike-wave bursts)Baseline and at 3 months post treatment30 minute routine EEG including hyperventilation to induce seizures, compare 3 months to baseline

Countries

United States

Contacts

CONTACTEric H Kossoff, MD
ekossoff@jhmi.edu4109559100
PRINCIPAL_INVESTIGATOREric H Kossoff, MD

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026