Using ketone esters to treat drug-resistant epilepsy in children
Efficacy of Ketone Esters for Children With Drug Resistant Epilepsy
This study is testing if ketone esters can help children with drug-resistant epilepsy control their seizures better than the traditional ketogenic diet.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 16 Years |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT05670847 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of exogenous ketone esters as an add-on treatment for children suffering from drug-resistant epilepsy. It aims to provide a more convenient alternative to the traditional ketogenic diet, which can be difficult to adhere to and may cause adverse effects. The trial will involve children who experience a high frequency of seizures, assessing the impact of ketone esters on seizure control. The study is designed to evaluate both the safety and efficacy of this intervention in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with drug-resistant epilepsy who experience seven or more seizures per week.
Not a fit: Patients with severe underlying health conditions or those who have recently modified their diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, more manageable option for controlling seizures in children with drug-resistant epilepsy.
How similar studies have performed: While the ketogenic diet has been established for treating epilepsy, the use of exogenous ketone esters is a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Drug-resistant epilepsy * Seizure frequency ≥ 7 per week Exclusion Criteria: * Failure to obtain informed consent * Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications * Severe disease conditions, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems * Hypo-/hyperglycemia * Metabolic acidosis * Ketosis (βHB \> 2 mmol/L) * GIT disorders, including gastritis/peptic ulcer, diarrhea/constipation, and irritable bowel disease * Malnutrition/obesity * Limitations to oral feeding (e.g., severe gastroesophageal reflux) * Inborn errors of metabolism * Chromosomal disorders * Surgically-remediable epilepsy * Allergies or any other contraindication to ketone supplements * Inapplicable recording of seizures * Incompliance to anti-seizure medications and/or irregular follow-up * Recent propofol therapy * Intake of carbonic-anhydrase inhibitors
Where this trial is running
Sohag
- Department of Pediatrics at Sohag University Hospital — Sohag, Egypt (Recruiting)
Study contacts
- Study coordinator: Elsayed M Abdelkreem, MD, PhD
- Email: d.elsayedmohammed@med.sohag.edu.eg
- Phone: 01114232126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.