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New treatment option for Generalized Convulsive Status Epilepticus
Official title Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children
ClinicalTrials.gov ID: NCT07046611
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for generalized convulsive 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
- About 40% of children with generalized convulsive status epilepticus (GCSE) are not terminated by first-line benzodiazepines (BDZs), and approximately 50% of BDZ-refractory GCSE are not controlled by second-line antiseizure medications. This study investigates the efficacy of ketamine-levetiracetam combination vs.
- 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
- Age from 1 year to 16 years.
- Generalized convulsive status epilepticus (GCSE), defined as clinically observed generalized tonic-clonic convulsions that continue or recur without...
- Benzodiazepine-refractory, defined as continuous or recurrent GCSE in the emergency room after receiving an adequate benzodiazepine dose, with the...
You likely can't join if
- Failure to obtain informed consent.
- Prior treatment with antiseizure medication or anticonvulsant sedatives other than benzodiazepines for the presenting GCSE episode.
- Endotracheal intubation before enrollment.
- Acute traumatic brain injury.
- Cardiac arrest/post-anoxic seizures
- Hypoglycemia or hyperglycemia.
See the full eligibility criteria
- Age from 1 year to 16 years.
- Generalized convulsive status epilepticus (GCSE), defined as clinically observed generalized tonic-clonic convulsions that continue or recur without complete regaining of consciousness in between for longer than 5...
- Benzodiazepine-refractory, defined as continuous or recurrent GCSE in the emergency room after receiving an adequate benzodiazepine dose, with the last dose administered within 5 to 30 minutes.
- Failure to obtain informed consent.
- Prior treatment with antiseizure medication or anticonvulsant sedatives other than benzodiazepines for the presenting GCSE episode.
- Endotracheal intubation before enrollment.
- Acute traumatic brain injury.
- Cardiac arrest/post-anoxic seizures
- Hypoglycemia or hyperglycemia.
- Known allergies or contraindications to ketamine or levetiracetam
- Failure to obtain intravenous access.
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.