NCT05674552RecruitingPhase 2/3
Exogenous Ketone Esters for Refractory Status Epileptics
Efficacy of Exogenous Ketone Esters for Children With Refractory Convulsive Status Epileptics
Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 18 Dec 2022
- Start date
- 10 Jan 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Sohag University
- Diseases
- Epilepsy
- NCT number
- NCT05674552
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 50
- From 10 Jan 2023 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent (within the last 24 hours) propofol therapy.
- Intake of carbonic-anhydrase inhibitors.
Other illness
- Failure to obtain informed consent.
- Associated severe disease condition, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems.
- Allergies or any other contraindication to exogenous ketone esters.
Lab values
- Ketosis (βHB \> 2 mmol/L).
Other
- Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications.
- Hemodynamic or cardio-respiratory instability.
- Traumatic brain injury.
- Hypo-/hyperglycemia.
- Metabolic acidosis.
- Malnutrition/obesity.
- Limitations to nasogastric tube feeding.
- Inborn errors of metabolism.
Who the study is looking for
- Refractory Generalized convulsive status epilepticus.
Age in the registry: 1 year to 10 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Pediatrics at Sohag University Hospital Coordinator of this site? Confirm its status | Sohag | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.