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New treatment option for Drug Resistant Epilepsy
Official title Exogenous Ketone Esters for Drug Resistant Epilepsy
ClinicalTrials.gov ID: NCT05670847
What this study is testing
What is Exogenous ketone ester?
Exogenous ketone ester is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for drug resistant epilepsy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 16
You may be able to join if
- Drug-resistant epilepsy
- Seizure frequency ≥ 7 per week
You likely can't join if
- 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)
See the full eligibility criteria
- Drug-resistant epilepsy
- Seizure frequency ≥ 7 per week
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sohag, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sohag, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.