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New treatment option for Status Epilepticus
Official title Exogenous Ketone Esters for Refractory Status Epileptics
ClinicalTrials.gov ID: NCT05674552
What this study is testing
What is Exogenous ketone ester?
Exogenous ketone ester is an investigational medicine, being studied as a potential treatment for status epilepticus.
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 the treatment of children with refractory generalized convulsive status epilepticus
- 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 10
You may be able to join if
- Refractory Generalized convulsive status epilepticus.
You likely can't join if
- 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.
See the full eligibility criteria
- Refractory Generalized convulsive status epilepticus.
- 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.
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 10 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.