Ketogenic Diet for New-Onset Absence Epilepsy

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04274179
Phase
PHASE3
Status
Recruiting
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Conditions

  • Absence Epilepsy
  • Epilepsy, Absence
  • Ketogenic Dieting

Eligibility Criteria

Sex
ALL
Age
3 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Modified Atkins Diet — OTHER
    Low carb (20g/day), high fat, moderate protein diet. Started as an outpatient in clinic.
  • Absence epilepsy medications — DRUG
    At neurologist's discretion. \*OF NOTE\< THIS ARM IS COMPLETED

Study Details

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.

Key Dates

Start date
Aug 10, 2020
Status verified
May 2026
Primary completion
May 1, 2028
Completion
May 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in seizure frequency [ Time Frame: At 1 and 3 months post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Eric H Kossoff, MD
[email protected]
410-955-9100
Eric H Kossoff, MD (PRINCIPAL_INVESTIGATOR)
Zahava Turner, RD (SUB_INVESTIGATOR)
Courtney Haney, RD (SUB_INVESTIGATOR)
Eva Catenaccio, MD (SUB_INVESTIGATOR)
Danielle DeCampo, MD (SUB_INVESTIGATOR)
Rachel Penn, MD (SUB_INVESTIGATOR)
Ania Dabrowski, MD (SUB_INVESTIGATOR)
Lindsay Schleifer, MD (SUB_INVESTIGATOR)

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Johns Hopkins Hospital· Baltimore, MD

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