NCT07095842 Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)
| NCT ID | NCT07095842 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sohag University |
| Condition | Convulsive Status EPILEPTICUS |
| Study Type | INTERVENTIONAL |
| Enrollment | 668 participants |
| Start Date | 2025-08-03 |
| Primary Completion | 2026-07-30 |
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 668 participants in total. It began in 2025-08-03 with a primary completion date of 2026-07-30.
⚠ 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
The goal of this pragmatic, decentralized, pre-consented, event-driven, randomized controlled trial is to investigate the efficacy of add-on ketamine to second-dose midazolam for prehospital treatment of epileptic children with convulsive status epilepticus.
Eligibility Criteria
Inclusion Criteria: * Age from 2 to 16 years. * Established diagnosis of epilepsy of at least 1 year duration. * History of at least 1 episode of convulsive status epilepticus in the preceding 12 months. Exclusion Criteria: * Failure to obtain informed consent. * Known allergies or contraindications to ketamine. * Known contraindications to intramuscular injection. * Presence of another family member included in the same trial. * Having subsequent events (only the index event will be included).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07095842 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 16 Years, studying 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 NCT07095842 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 NCT07095842 currently recruiting?
Yes, NCT07095842 is actively recruiting participants. Contact the research team at d.elsayedmohammed@med.sohag.edu.eg for enrollment information.
Where is the NCT07095842 trial being conducted?
This trial is being conducted at Sohag, Egypt.
Who is sponsoring the NCT07095842 clinical trial?
NCT07095842 is sponsored by Sohag University. The trial plans to enroll 668 participants.