Ketogenic Diet for New-Onset Absence Epilepsy

NCT04274179 | Recruiting Phase 3 FDA Drug

• 1 other identifier: IRB00241856
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Absence Epilepsy; Ketogenic Dieting; Epilepsy, Absence

Keywords

ketogenic; diet; absence

Outcome Measures

Primary Outcomes (1)

• Change in seizure frequency

  Parental report of seizure frequency.

  At 1 and 3 months post treatment

Secondary Outcomes (5)

• Tolerability of diet therapy as assessed by restrictiveness of the diet therapy

  At 3 months

• Tolerability of diet therapy as assessed by restrictiveness of the diet therapy

  At 6 months

• Duration of diet therapy

  Up to 3 months post treatment

• Tolerability of diet therapy as assessed by change in urinary ketones

  At 1 and 3 months post treatment

• EEG changes (normalization of the baseline spike-wave bursts)

  Baseline and at 3 months post treatment

Study Arms (2)

Diet therapy

EXPERIMENTAL

Modified Atkins Diet - high fat, low carbohydrate, outpatient initiated approach. Parents will check urine ketones twice weekly and follow by email, phone and clinic. Labs at baseline and 3 months. Dietitian support.

Other: Modified Atkins Diet

Drug therapy

ACTIVE COMPARATOR

Families will have the usual care for absence epilepsy at the discretion of the family's neurologist and the family choice. Typically ethosuximide bis in die (BID), however, if convulsions have occurred or other factors are involved, the child may be started on valproate or lamotrigine. The child will continue medications with dose adjustment and antiseizure drug levels checked as usual. \*\*OF NOTE, THIS ARM IS COMPLETED

Drug: Absence epilepsy medications

Interventions

Modified Atkins Diet OTHER

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

Diet therapy

Absence epilepsy medications DRUG

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

Also known as: Ethosuximide, valproate or lamotrigine

Drug therapy

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (2)

• Groomes LB, Pyzik PL, Turner Z, Dorward JL, Goode VH, Kossoff EH. Do patients with absence epilepsy respond to ketogenic diets? J Child Neurol. 2011 Feb;26(2):160-5. doi: 10.1177/0883073810376443. Epub 2010 Jul 20.

  PMID: 20647578 BACKGROUND

• Kossoff EH, Hedderick EF, Turner Z, Freeman JM. A case-control evaluation of the ketogenic diet versus ACTH for new-onset infantile spasms. Epilepsia. 2008 Sep;49(9):1504-9. doi: 10.1111/j.1528-1167.2008.01606.x. Epub 2008 Apr 10.

  PMID: 18410363 BACKGROUND

MeSH Terms

Conditions

Epilepsy, Absence

Interventions

Ethosuximide; Valproic Acid; Lamotrigine

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Succinimides; Imides; Organic Chemicals; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids; Triazines

Study Officials

• Eric H Kossoff, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric H Kossoff, MD

CONTACT

4109559100; ekossoff@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: August 10, 2020
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)