Phase 3 N=478 Randomized Triple-blind Treatment

Established Status Epilepticus Treatment Trial

Benzodiazepine Refractory Status Epilepticus

Bottom Line

View on ClinicalTrials.gov: NCT01960075 ↗

Enrolled (actual)

478

Serious AEs

41.8%

Results posted

Feb 2020

Primary outcome: Primary: Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat — 53; 56; 68 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fosphenytoin (Drug); Levetiracetam (Drug); Valproic acid (Drug)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: University of Virginia
Primary completion: Feb 2019

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	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT01960075). 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.