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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Exogenous Ketone Esters for Drug Resistant Epilepsy

Efficacy of Ketone Esters for Children With Drug Resistant Epilepsy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Drug-resistant epilepsy - Seizure frequency ≥ 7 per week Who Should NOT Join This Trial: - Failure to obtain willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Exogenous ketone ester

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

Locations (1)

Department of Pediatrics at Sohag University Hospital
Sohag, Egypt