Exogenous Ketone Esters for Drug Resistant Epilepsy

Phase 3RecruitingNCT05670847

Sohag University60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug Resistant Epilepsy

Interventions

Exogenous ketone esterDRUG

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Pediatrics at Sohag University Hospital

Sohag, Egypt

RECRUITING

Outcomes

Primary Outcomes

≥ 50% reduction in seizure frequency

Proportion of patients achieving ≥ 50% reduction in seizure frequency

Time frame: From 28-days observation (baseline) phase to 28-days intervention phase

Secondary Outcomes

Proportion of incompliance to exogenous ketone ester therapy

Proportion of doses of exogenous ketone esters which were not administered by patients (as recorded by parents of included children)

Time frame: 28-days intervention phase

Proportion of incompliance to anti-seizure medications (ASMs)

Proportion of doses of anti-seizure medications (ASMs) which were not administered by children (as recorded by parents of included children)

Time frame: From 28-days observation (baseline) phase to 28-days intervention phase

Change in seizure severity assessed by National Hospital Seizure Severity Scale (NHS3)

Time frame: From 28-days observation (baseline) phase to 28-days intervention phase

Change in seizure frequency

Change in the number of seizures (as recorded by parents of included children)

Time frame: From 28-days observation (baseline) phase to 28-days intervention phase

Change in frequency of status epilepticus

Change in the number of episodes of status epilepticus (evaluated from patient's medical records)

Time frame: From 28-days observation (baseline) phase to 28-days intervention phase

Change in occurrence of possible adverse effects

Central Contacts

Elsayed M Abdelkreem, MD, PhD

CONTACT

01114232126 d.elsayedmohammed@med.sohag.edu.eg

Data from ClinicalTrials.gov

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