NCT05670847RecruitingPhase 2/3
Exogenous Ketone Esters for Drug Resistant Epilepsy
Efficacy of Ketone Esters for Children With Drug Resistant Epilepsy
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 treating children with drug-resistant epilepsy
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 60 (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
- NCT05670847
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 60
- 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
- Recent propofol therapy
- Intake of carbonic-anhydrase inhibitors
Other illness
- Failure to obtain informed consent
- Severe disease conditions, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems
- GIT disorders, including gastritis/peptic ulcer, diarrhea/constipation, and irritable bowel disease
- 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
Lab values
- Ketosis (βHB \> 2 mmol/L)
Other
- Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications
- Hypo-/hyperglycemia
- Metabolic acidosis
- Malnutrition/obesity
- Limitations to oral feeding (e.g., severe gastroesophageal reflux)
- Inborn errors of metabolism
Who the study is looking for
- Drug-resistant epilepsy
- Seizure frequency ≥ 7 per week
Age in the registry: 1 year to 16 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.