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

Who is this study for? Patients with Absence Epilepsy, Ketogenic Dieting
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Eric H Kossoff, MD
ekossoff@jhmi.edu
4109559100
Time Frame
Start Date: 2020-08-10
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 40
Treatments
Experimental: Diet therapy
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.
Active_comparator: Drug therapy
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
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov