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Dietary Intervention

Ketogenic Diet vs Medication for Childhood Absence Epilepsy

Phase 3

Recruiting

Led By Eric H Kossoff, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children ages 3-12 years at seizure onset with classic childhood absence epilepsy clinically

Daily reported absence seizures

Must not have

Glut1 deficiency syndrome

Previous treatment with any anticonvulsant drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 and 3 months post treatment

Awards & highlights

Approved for 5 Other Conditions

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is to assess if the modified Atkins diet is a feasible and effective option for new-onset childhood absence epilepsy, as compared to a group of children in which the parents have declined and chose to start anticonvulsant medications.

Who is the study for?

This trial is for children aged 3-12 with new-onset childhood absence epilepsy, who experience daily seizures and have specific EEG patterns. They should be generally healthy or have mild disabilities. Kids who've tried a ketogenic diet, taken seizure meds before, or have certain metabolic disorders can't join.

What is being tested?

The study is testing if a modified Atkins Diet (high fat, low carb) can help manage seizures in kids with new-onset absence epilepsy compared to those whose parents choose standard seizure medications instead.

What are the potential side effects?

Potential side effects of the modified Atkins Diet may include digestive issues due to high fat intake and possible nutrient deficiencies without careful planning. Seizure medications typically carry risks like dizziness, fatigue, and more serious effects depending on the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child had absence seizures start between ages 3-12.

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I experience daily absence seizures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Glut1 deficiency syndrome.

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I have taken medication for seizures before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 and 3 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 and 3 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 3 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in seizure frequency

Secondary study objectives

Duration of diet therapy

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

Tolerability of diet therapy as assessed by change in urinary ketones

+1 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Diet therapyExperimental Treatment1 Intervention

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.

Group II: Drug therapyActive Control1 Intervention

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

0 / 4Eligibility criteria met