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Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)

Study acronym: KESETT
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial sites expanded: 52 → 63 locations Show 4 more changesShow less
    • Interventions: Levetiracetam (LEV) (60 mg/Kg) (Drug), Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET) (Drug), Levetiracetam (LEV) (60 mg/Kg) + 3… to Levetiracetam (LEV) (60 mg/Kg) (Drug), Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET) (Drug), Levetiracetam (LEV) (60 mg/Kg) + 3…
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Collaborators: details revised at 1 of 4 entries
  2. Study sites: 51 to 52v7
  3. Trial sites expanded: 47 → 51 locationsv6
  4. Trial sites expanded: 31 → 47 locations
    • Start date changed from estimate of Feb 2026 to Mar 6, 2026
    v5
  5. Study sites: 28 to 31v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2026 to Feb 2026
    • Site details revised at 28 of 28 sites
    v3
  2. Start date: Aug 2025 to Jan 2026
    • Study sites: 0 to 28
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to determine if treatment of patients with two doses of ketamine plus levetiracetam versus levetiracetam alone leads to more effective control of status epilepticus.
Trial Details
NCT Number NCT06907173
Lead Sponsor University of Virginia
Collaborators: University of Michigan, Medical University of South Carolina, Massachusetts General Hospital, Children's National Research Institute
Conditions
(from sponsor)		 Status Epilepticus
Related terms Status Epilepticus
Enrollment 770 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov