Ketamine added to levetiracetam to stop prolonged convulsive seizures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

KESETT is a multicenter, randomized, blinded Phase 3 trial comparing levetiracetam alone (60 mg/kg) to levetiracetam plus ketamine at 1 mg/kg or 3 mg/kg in patients with convulsive seizures that continued after benzodiazepines. The primary outcome is stopping status epilepticus from 15 minutes after the start of the study infusion and keeping it stopped through 60 minutes without additional antiseizure drugs, determined by clinical improvement or EEG when available. The trial uses an initial 1:1:1 allocation for the first 350 participants then switches to response-adaptive randomization, with interim analyses for efficacy and futility and a maximum enrollment of 770 subjects. Safety outcomes, adverse events, and pediatric-specific effectiveness and safety are secondary objectives.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The patient was witnessed to have a convulsive seizure for greater than 5-minute duration
* The patient received an adequate dose of benzodiazepines. The doses may be divided.
* The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.
* Continued or recurring seizures in the Emergency Department.
* Age 1 years or older
* Known or estimated weight ≥10 Kg

Exclusion Criteria:

* Known pregnancy
* Prisoner
* Opt-out identification or otherwise known to be previously enrolled in KESETT
* Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital, or other agents defined in the MoP) for this episode of SE
* Treatment with sedatives with anticonvulsant properties other than benzodiazepines for this episode of SE(propofol, etomidate, ketamine or other agents defined in the MoP)
* Endotracheal intubation prior to enrollment
* Acute traumatic brain injury clearly precedes seizures
* Scalp injury or burn preventing EEG placement
* Known allergy or other known contraindication to KET or LEV
* Hypoglycemia \< 50 mg/dL
* Hyperglycemia \> 400 mg/dL
* Cardiac arrest / post-anoxic seizures

Where it's running

• Banner University Medical Center - Tucson Campus
  Tucson, Arizona, United States Recruiting
• Stanford University Medical Center
  Palo Alto, California, United States Recruiting
• UC Davis Medical Center
  Sacramento, California, United States Recruiting
• San Francisco General Hospital
  San Francisco, California, United States Recruiting
• UCSF Medical Center
  San Francisco, California, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting

+13 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Jaideep Kapur, MD, PhD — University of Virginia
• Study coordinator: Megan Wardius
• Email: mew5j@virginia.edu
• Phone: 434-243-6768

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.