Established Status Epilepticus Treatment Trial (ESETT)
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|ClinicalTrials.gov Identifier: NCT01960075|
Recruitment Status : Recruiting
First Posted : October 10, 2013
Last Update Posted : January 5, 2018
The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA).
The second objective is comparison of three drugs with respect to secondary outcomes.
The final objective is to ensure that the trial is informative for treatment of established SE in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.
|Condition or disease||Intervention/treatment||Phase|
|Benzodiazepine Refractory Status Epilepticus||Drug: Fosphenytoin Drug: Levetiracetam Drug: Valproic acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||795 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Blinded, Comparative Effectiveness Study of Fosphenytoin, Valproic Acid, or Levetiracetam in the Emergency Department Treatment of Patients With Benzodiazepine-refractory Status Epilepticus.|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||July 2020|
Active Comparator: Fosphenytoin (FOS)
Administer 20 mg/Kg fosphenytoin intravenously up to a maximum dose of 1500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 1500 fosphenytoin over 10 minutes.
Active Comparator: Valproic acid
Administer 40 mg/Kg valproic acid intravenously up to a maximum dose of 3000 mg (75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 3000 valproic acidover 10 minutes.
|Drug: Valproic acid|
Active Comparator: Levetiracetam
Administer 60 mg/Kg levetiracetam intravenously up to a maximum dose of 4500 mg ( 75 Kg) over 10 minutes. Those weighing more than 75 Kg receive a fixed dose of 4500 levetiracetam over 10 minutes.
- Clinical cessation of status epilepticus [ Time Frame: Within 60 minutes after the start of study drug infusion ]Determined by the absence of clinically apparent seizures and improving responsiveness without the use of additional anti-seizure medication
- Occurrence of life threatening hypotension or cardiac arrhythmia [ Time Frame: Within 60 minutes after the start of study drug infusion ]
- Admission to ICU [ Time Frame: 7 days from enrollment ]
- Time to termination of seizures [ Time Frame: Within 60 minutes after the start of study drug infusion ]
- Intubation [ Time Frame: Within 60 minutes after the start of study drug infusion ]
- Seizure recurrence [ Time Frame: Within 60 minutes after the start of study drug infusion ]
- Mortality [ Time Frame: Within 30 days of randomization ]
- Richmond agitation and sedation score [ Time Frame: Within 60 minutes after the start of study drug infusion ]
- Length of stay in the ICU and hospital [ Time Frame: Within 30 days of randomization ]
- Effectiveness in children [ Time Frame: Within 60 minutes after the start of study drug infusion ]Final objective is to determine the effectiveness, rate of adverse reactions of these drugs in children with established status epilepticus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960075
|Contact: Jaideep Kapur, MBBS, PhDfirstname.lastname@example.org|
|Contact: Sonya Gunteremail@example.com|
Show 65 Study Locations
|Study Chair:||Jaideep Kapur, MBBS, PhD||University of Virginia|
|Principal Investigator:||Robert Silbergleit, MD||University of Michigan|
|Principal Investigator:||James Chamberlain, MD||Children's National Health System|
|Principal Investigator:||Jordan Elm, PhD||Medical University of South Carolina|