RecruitingPhase 2Phase 3NCT05670847

Exogenous Ketone Esters for Drug Resistant Epilepsy

Efficacy of Ketone Esters for Children With Drug Resistant Epilepsy

Sponsor

Sohag University

Enrollment

60 participants

Start Date

Jan 10, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 16 Years

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

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DRUGExogenous ketone ester

500 mg/kg orally three times daily (with at least 4 hours between each dose) for 28 days

Department of Pediatrics at Sohag University Hospital

Sohag, Egypt

View Full Details on ClinicalTrials.gov

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NCT05670847