RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
Exogenous Ketone Esters for Drug Resistant Epilepsy
Efficacy of Ketone Esters for Children With Drug Resistant Epilepsy
About This Trial
This study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy
Who May Be Eligible (Plain English)
Who May Qualify:
- Drug-resistant epilepsy
- Seizure frequency ≥ 7 per week
Who Should NOT Join This Trial:
- Failure to obtain willing to sign a consent form
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Exogenous ketone ester
500 mg/kg orally three times daily (with at least 4 hours between each dose) for 28 days
Locations (1)
Department of Pediatrics at Sohag University Hospital
Sohag, Egypt