Tests ketone esters added to usual care for children with drug-resistant epilepsy
Tests ketone esters added to usual medicine in children with hard-to-control epilepsy.
Key facts
- Who runs it
- Sohag University
- Where
- Sohag, EgyptSee the site
- Trial code
- Registry title
- Exogenous Ketone Esters for Drug Resistant Epilepsy
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 60 people, planned
- Started
- 10 Jan 2023
- Planned end
- 1 Jul 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Exogenous ketone ester
- Record updated
- 27 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with epilepsy that does not respond to medicines and who have frequent seizures. It tests ketone esters as an added treatment.
- Age
- From 1 Year to 16 Years
- Sex
- All sexes can join.
- Disease stage
- Drug-resistant epilepsy with seizure frequency ≥ 7 per week.
- Earlier treatment
- Must not have recently taken exogenous ketones, followed a ketogenic diet, or had any dietary restrictions or changes. Must not have had recent propofol therapy or take carbonic-anhydrase inhibitors.
Main reasons for not taking part
- Severe disease of the liver, kidneys, lungs, heart, gut, hormones or immune system
- Low or high blood sugar, metabolic acidosis, or ketosis (βHB > 2 mmol/L (36 mg/dL))
- Inborn errors of metabolism or chromosomal disorders
- Epilepsy that can be treated by surgery
- Not taking anti-seizure medicines regularly or irregular follow-up
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Drug-resistant epilepsy
- Seizure frequency ≥ 7 per week
Who cannot take part
- Recent propofol therapy
- Intake of carbonic-anhydrase inhibitors
- Failure to obtain informed consent
- Severe disease conditions, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems
- GIT disorders, including gastritis/peptic ulcer, diarrhea/constipation, and irritable bowel disease
- 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
- Ketosis (βHB > 2 mmol/L)
- Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications
- Hypo-/hyperglycemia
- Metabolic acidosis
- Malnutrition/obesity
- Limitations to oral feeding (e.g., severe gastroesophageal reflux)
- Inborn errors of metabolism
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 16 years old?
Where in Egypt
- Department of Pediatrics at Sohag University HospitalSohag, EgyptContact: Abdelrahim A Sadek, MD, PhDTaking people
About the trial
What the trial wants to find out
This study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy
The 2 groups in the trial
- Study groupTreatment being tested
Children receiving exogenous ketone esters + standard of care
Treatment: Exogenous ketone ester
- Control groupNo study treatment, for comparison
Children receiving only standard of care
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of Ketone Esters for Children With Drug Resistant Epilepsy
- Plain-language title
- Tests ketone esters added to usual care for children with drug-resistant epilepsyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05670847, who can take part
- Record updated
- 27 November 2024