A Phase 2/3 interventional study of Exogenous ketone ester in Drug Resistant Epilepsy, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Sohag University · Phase 2/3, Interventional, and Treatment
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.
270 studies on the registry are indexed under Drug Resistant Epilepsy; 100 are open to participants now.
This study's planned enrollment of 60 is above the median of 30 across 213 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →Sohag University is the lead sponsor of 1,220 studies on the registry; 629 are open to participants now.
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Exclusion Criteria:
Children receiving exogenous ketone esters + standard of care
Drug: Exogenous ketone ester
Children receiving only standard of care
500 mg/kg orally three times daily (with at least 4 hours between each dose) for 28 days
≥ 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
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)
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
Change in occurrence of possible adverse effects
Time frame: From 28-days observation (baseline) phase to 28-days intervention phase
Change in cognitive domains
Change in attention, alertness, and memmory, each rated by parents of included children at the end of 28-days intervention phase as no change, improvement, or regression in comparison with the preceding 28-days observation phase
Time frame: From 28-days observation (baseline) phase to 28-days intervention phase
Change in blood βHB
Change in blood level of beta-hydroxybutyrate
Time frame: From baseline to 30 minutes, 1 hour, 2 hours, 4 hours, 2 days, 4 days, 7 days, 14 days, and 28 days study timepoints
Change in blood glucose
Change in blood level of glucose
Time frame: From baseline to 30 minutes, 1 hour, 2 hours, 4 hours, 2 days, 4 days, 7 days, 14 days, and 28 days study timepoints
Change in blood pH
Change in blood level of pH
Time frame: From baseline to 30 minutes, 1 hour, 2 hours, 4 hours, 2 days, 4 days, 7 days, 14 days, and 28 days study timepoints
Change in EEG score
Change in EEG score according to the scale developed by Walker \& Said (2014), which includes items related to encephalopathy, interictal epileptic discharge, and seizure presence
Time frame: From baseline to 28 days study timepoint
Change in blood lactate level
Change in blood level of lactate
Time frame: From baseline to 30 minutes, 1 hour, 2 hours, 4 hours, 2 days, 4 days, 7 days, 14 days, and 28 days study timepoints
Change in blood bicarbonate level
Change in blood level of bicarbonate
Time frame: From baseline to 30 minutes, 1 hour, 2 hours, 4 hours, 2 days, 4 days, 7 days, 14 days, and 28 days study timepoints
Change in serum sodium level
Change in serum sodium level
Time frame: From baseline to 30 minutes, 1 hour, 2 hours, 4 hours, 2 days, 4 days, 7 days, 14 days, and 28 days study timepoints
Change in serum potassium level
Change in serum potassium level
Time frame: From baseline to 30 minutes, 1 hour, 2 hours, 4 hours, 2 days, 4 days, 7 days, 14 days, and 28 days study timepoints
Change in hematological counts
Change in hematological counts
Time frame: From baseline to 28 days study timepoint
Change in blood triglycerides level
Change in blood triglycerides level
Time frame: From baseline to 28 days study timepoint
Change in blood free fatty acids level
Change in blood free fatty acids level
Time frame: From baseline to 28 days study timepoint
Change in blood cholesterol level
Change in blood cholesterol level
Time frame: From baseline to 28 days study timepoint
Change in HbA1c
Change in hbA1c
Time frame: From baseline to 28 days study timepoint
Change in blood alanine transaminase level
Change in blood level of alanine transaminase enzyme (ALT)
Time frame: From baseline to 28 days study timepoint
Change in serum creatinine level
Change in serum level of creatinine
Time frame: From baseline to 28 days study timepoint
Plan to share: Yes — Unidentified individual participant data (IPD) underlying study results will be available upon reasonable request
Supporting information: Study protocol, Statistical analysis plan
Time frame: Unidentified individual participant data (IPD) underlying study results will be available upon reasonable request 6-months after publication
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