Exogenous Ketone Esters for Drug Resistant Epilepsy

Conditions: Drug Resistant Epilepsy

Sex: All

Ages: 1 Year – 16 Years

Phase: PHASE2, PHASE3

Enrollment: 60

Sponsor: Sohag University

Location: Egypt

Summary

This study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy

Eligibility Criteria

Inclusion Criteria:Drug-resistant epilepsySeizure frequency ≥ 7 per weekExclusion Criteria:Failure to obtain informed consentRecent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modificationsSevere disease conditions, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systemsHypo-/hyperglycemiaMetabolic acidosisKetosis (βHB > 2 mmol/L)GIT disorders, including gastritis/peptic ulcer, diarrhea/constipation, and irritable bowel diseaseMalnutrition/obesityLimitations to oral feeding (e.g., severe gastroesophageal reflux)Inborn errors of metabolismChromosomal disordersSurgically-remediable epilepsyAllergies or any other contraindication to ketone supplementsInapplicable recording of seizuresIncompliance to anti-seizure medications and/or irregular follow-upRecent propofol therapyIntake of carbonic-anhydrase inhibitors

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05670847). StuddyBuddy aggregates publicly available trial information.