NCT05670847 Exogenous Ketone Esters for Drug Resistant Epilepsy
| NCT ID | NCT05670847 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sohag University |
| Condition | Drug Resistant Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-10 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-01-10 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy
Eligibility Criteria
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
Contact & Investigator
Abdelrahim A Sadek, MD, PhD
STUDY CHAIR
Sohag University
Frequently Asked Questions
Who can join the NCT05670847 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 16 Years, studying Drug Resistant Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05670847 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05670847 currently recruiting?
Yes, NCT05670847 is actively recruiting participants. Contact the research team at d.elsayedmohammed@med.sohag.edu.eg for enrollment information.
Where is the NCT05670847 trial being conducted?
This trial is being conducted at Sohag, Egypt.
Who is sponsoring the NCT05670847 clinical trial?
NCT05670847 is sponsored by Sohag University. The principal investigator is Abdelrahim A Sadek, MD, PhD at Sohag University. The trial plans to enroll 60 participants.
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