RecruitingPhase 2Phase 3NCT05670847
Exogenous Ketone Esters for Drug Resistant Epilepsy
Efficacy of Ketone Esters for Children With Drug Resistant Epilepsy
Sponsor
Sohag University
Enrollment
60 participants
Start Date
Jan 10, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy
Eligibility
Min Age: 1 YearMax Age: 16 Years
Inclusion Criteria2
- Drug-resistant epilepsy
- Seizure frequency ≥ 7 per week
Exclusion Criteria17
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGExogenous ketone ester
500 mg/kg orally three times daily (with at least 4 hours between each dose) for 28 days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05670847
Related Trials
Epileptogenic Network Visualisation With Advanced MRI
NCT060591571 location
Evaluate the effectiveness of personalised Deep Brain Stimulation
ACTRN126260005693031 location
A PET-MRI Study of Serotoninergic Brainstem Pathway in Patients With Dravet Syndrome
NCT070133311 location
MiCrobiota-gut-brain Axis in Resistant Epilepsy
NCT070104451 location
A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
NCT064927201 location