NCT07046611 Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children
| NCT ID | NCT07046611 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sohag University |
| Condition | Generalized Convulsive Status Epilepticus |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2026-06-30 |
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 124 participants in total. It began in 2025-07-02 with a primary completion date of 2026-06-30.
⚠ 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
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. levetiracetam alone for treating children with BDZ-refractory GCSE.
Eligibility Criteria
Inclusion 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 minutes. * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07046611 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 16 Years, studying Generalized Convulsive Status Epilepticus. 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 NCT07046611 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 NCT07046611 currently recruiting?
Yes, NCT07046611 is actively recruiting participants. Contact the research team at d.elsayedmohammed@med.sohag.edu.eg for enrollment information.
Where is the NCT07046611 trial being conducted?
This trial is being conducted at Sohag, Egypt.
Who is sponsoring the NCT07046611 clinical trial?
NCT07046611 is sponsored by Sohag University. The trial plans to enroll 124 participants.