Exogenous Ketone Esters for Drug Resistant Epilepsy

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sohag University

Criteria

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