Exogenous Ketone Esters for Drug Resistant Epilepsy

Recruiting now · Phase 2/Phase 3

Conditions studied: Drug Resistant Epilepsy

In brief

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

Key facts

Study ID

NCT05670847

Run by

Sohag University

People needed

60

Starts

2023-01-10

Expected to finish

2025-07-01

Last updated by the study team

2024-11-27

Who can join

Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Drug-resistant epilepsy
• Seizure frequency ≥ 7 per week

You may not qualify if…

• 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

Where it is running

• Department of Pediatrics at Sohag University Hospital — Sohag, Egypt (enrolling)

Full record on ClinicalTrials.gov

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