NCT05670847

Exogenous Ketone Esters for Drug Resistant Epilepsy

Efficacy of Ketone Esters for Children With Drug Resistant Epilepsy

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Drug Resistant Epilepsy

Interventions

Type	Name	Description
DRUG	Exogenous ketone ester	500 mg/kg orally three times daily (with at least 4 hours between each dose) for 28 days

Timeline

• Start date: 2023-01-10
• Primary completion: 2025-06-30
• Completion: 2025-07-01
• First posted: 2023-01-04
• Last updated: 2024-11-27

Locations

1 site across 1 country: Egypt