Exogenous Ketone Esters for Drug Resistant Epilepsy (EKEDRE)

Sohag University

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Drug Resistant Epilepsy

Treatments

Drug: Exogenous ketone ester

Study type

Interventional

Funder types

Other

Identifiers

NCT05670847

Soh-Med-22-12-45

Details and patient eligibility

About

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

Full description

Epilepsy is a common neurological disorder among children with significant neurobiological, cognitive, psychological, and social consequences. Seizures can usually be controlled by anti-seizure medications (ASMs) in up to two-thirds of children with epilepsy. However, this leaves a significant part of epileptic children whose seizures are not controlled by pharmacotherapy. Currently, available alternatives for drug-resistant epilepsy (DRE) include surgery, vagus nerve stimulation, and ketogenic diet (KD).

KD has been classically used for treating children with DRE. However, KD requires strict dietary restriction, which may not be applicable or acceptable for many patients, and is associated with several adverse effects, commonly including gastrointestinal (e.g., constipation, nausea, vomiting), cardiovascular (e.g., dyslipidemia), renal/genitourinary (e.g., renal calculi), and growth problems. Exogenous ketone esters (EKE) could be a more convenient and superior alternative to KD for children with DRE.

Enrollment

60 estimated patients

Sex

All

Ages

1 to 16 years old

Volunteers

No Healthy Volunteers

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