Using ketone esters to treat drug-resistant epilepsy in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Modified ketogenic diet for adults with drug-resistant epilepsy

  This study tests whether a modified ketogenic diet can help adults with drug-resistant epilepsy see fewer seizures and feel better overall.

  Recruiting Karolinska Institutet · Stockholm · NCT07878104

• Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

  This study tests whether low intensity focused ultrasound can help reduce seizures in adults with drug‑resistant epilepsy.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07680842

• iVEAcare Neuromodulation System for drug‑resistant epilepsy: a feasibility look

  This study tests whether the iVEAcare neuromodulation system is safe and can help reduce seizures and improve quality of life in people with drug‑resistant epilepsy.

  Recruiting at 7 sites iVEAcare · Herston, Queensland and 6 other locations · NCT07640191

• Real-world use of the OneRF Ablation System for epilepsy

  This registry collects real-world outcomes and device performance from patients with drug-resistant epilepsy who are treated with SEEG-guided RF ablation using the OneRF system.

  Recruiting at 3 sites NeuroOne Medical Technologies Corporation · Miami, Florida and 2 other locations · NCT07546253

• Overnight Temporal Interference Stimulation for Temporal Lobe Epilepsy

  This study tests whether overnight, non-invasive temporal interference stimulation to the hippocampus can reduce seizure-related brain activity and improve sleep in adults with drug-resistant temporal lobe epilepsy.

  Recruiting Duke University · Durham, North Carolina · NCT07434986

• Biomarkers of Response to SEEG Thermocoagulation

  This study tests biomarkers to see if they predict how well SEEG-guided radiofrequency thermocoagulation helps people with drug-resistant focal epilepsy.

  Recruiting Assistance Publique Hopitaux De Marseille · Marseille · NCT07399327

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.