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Clinical Trials in Egypt / NCT05674552
Recruiting Phase 2/3

Exogenous Ketone Esters for Refractory Status Epileptics

NCT05674552 · tracked via the Priya Life Science Egypt tracker
Sponsor
Sohag University
Phase
Phase 2/3
Started
2023-01-10
Last updated
2024-11-27

Condition(s) studied

Status Epilepticus

Investigational drug(s) / intervention(s)

Exogenous ketone ester →

Exogenous ketone ester: 500 mg/kg over 5 min administered by nasogastric tube, followed after 1 hr by repeated hourly doses of 125 mg/kg for 8 hrs.

Study summary

This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus

Eligibility

Sex
ALL
Min age
1 Year
Max age
10 Years
Healthy volunteers
No
Inclusion Criteria: * Refractory Generalized convulsive status epilepticus. Exclusion Criteria: * Failure to obtain informed consent. * Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications. * Hemodynamic or cardio-respiratory instability. * Traumatic brain injury. * Hypo-/hyperglycemia. * Metabolic acidosis. * Ketosis (βHB \> 2 mmol/L). * Associated severe disease condition, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems. * Malnutrition/obesity. * Limitations to nasogastric tube feeding. * Inborn errors of metabolism. * Allergies or any other contraindication to exogenous ketone esters. * Current or recent (within the last 24 hours) propofol therapy. * Intake of carbonic-anhydrase inhibitors.

Primary outcome measure(s)

  • Proportion of patients achieving electroclinical cessation of seizures — 60 minutes
    Proportions of patients who achieve cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\])

Trial sites (1)

FacilityCityRegionStatus
Department of Pediatrics at Sohag University Hospital Sohag Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05674552 on ClinicalTrials.gov ↗ ← All trials in Egypt