Phase 3
Completed N=478
Established Status Epilepticus Treatment Trial
Benzodiazepine Refractory Status Epilepticus
Source: ClinicalTrials.gov NCT01960075 ↗
Enrolled (actual)
478
Serious AEs
41.8%
Results posted
Feb 2020
Primary outcomePrimary: Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat — 53; 56; 68 Participants
◆ Published Evidence
Established
90citations · ~18 / year
Patterns of benzodiazepine underdosing in the Established Status Epilepticus Treatment Trial.
Summary
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.
Linked Publications (5)
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Patterns of benzodiazepine underdosing in the Established Status Epilepticus Treatment Trial.
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Early Neurologic Recovery, Practice Pattern Variation, and the Risk of Endotracheal Intubation Following Established Status Epilepticus.
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Treatment of Toxin-Related Status Epilepticus With Levetiracetam, Fosphenytoin, or Valproate in Patients Enrolled in the Established Status Epilepticus Treatment Trial.
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A pharmacokinetic simulation study to assess the performance of a sparse blood sampling approach to quantify early drug exposure.
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Early Exposure of Fosphenytoin, Levetiracetam, and Valproic Acid After High-Dose Intravenous Administration in Young Children With Benzodiazepine-Refractory Status Epilepticus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat |
53; 56; 68 | — |
| PRIMARY Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis |
37; 43; 51 | — |
| PRIMARY Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis |
57; 60; 67 | — |
| SECONDARY Number of Participants With Admission to Intensive Care Unit |
70; 71; 87 | — |
| SECONDARY Length of ICU Stay |
1; 1; 1 | — |
| SECONDARY Minutes From Start of Trial Drug Infusion to Termination of Seizures for Patients With Treatment Success |
11.7; 7.0; 10.5 | — |
| SECONDARY Number of Participants With Seizure Cessation Within 20 Minutes for Patients With Treatment Success |
43; 43; 53 | — |
| SECONDARY Length of Hospital Stay |
3; 3; 3 | — |
Eligibility Criteria
Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. The doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2 years or older
Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; 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 (propofol, etomidate, ketamine or other agents defined in the MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder; Known liver disease; Known severe renal impairment; Known allergy or other known contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia 400 mg/dL; Cardiac arrest and post-anoxic seizures
Data sourced from ClinicalTrials.gov (NCT01960075) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.