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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 3 months post treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My child had absence seizures start between ages 3-12.
Select...
I experience daily absence seizures.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in seizure frequency
Secondary outcome measures
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 moreTrial 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
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,261 Previous Clinical Trials
14,821,028 Total Patients Enrolled
Eric H Kossoff, MDPrincipal InvestigatorJohns Hopkins University
7 Previous Clinical Trials
141 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not able to follow a high fat, low carbohydrate diet.You have had seizures in the past, except for febrile seizures.My child had absence seizures start between ages 3-12.You have a metabolic disorder that would prevent you from following a special diet.You have average or slightly impaired intellectual abilities.I experience daily absence seizures.I have had generalized seizures.I have been diagnosed with Glut1 deficiency syndrome.You have used a specific diet called the ketogenic diet for epilepsy or any other condition in the past.Your EEG shows specific patterns of brain activity during hyperventilation.I have taken medication for seizures before.
Research Study Groups:
This trial has the following groups:- Group 1: Drug therapy
- Group 2: Diet therapy
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the elderly welcome in this particular test program?
"This study only enrolls children that are between the ages of 3 and 12, as detailed in the inclusion criteria."
Answered by AI
What disorders does the Modified Atkins Diet typically help improve?
"The Modified Atkins Diet is frequently used to alleviate mental depression. It can also be used to manage behcet syndrome, complex partial seizures, and patients currently undergoing standardized therapy."
Answered by AI
What is the total number of subjects that will be enrolled in this clinical trial?
"Yes, as shown on clinicaltrials.gov, this trial is looking for 40 individuals to fill 1 vacant site. The posting date was August 10th, 2020 and the most recent update was on August 4th, 2022."
Answered by AI
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