CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,023 enrolled
Drug / intervention
Intramuscular route of active treatment +1 moredrug
Likely dose
Intramuscular route of active treatment 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00809146
NCT00809146Phase 3Completed
CompareCT.gov

A Double-blind Randomized Clinical Trial of the Efficacy of IM Midazolam Versus IV Lorazepam in the Pre-hospital Treatment of Status Epilepticus by Paramedics

Robert Silbergleit·interventional·Posted Dec 17, 2008·Updated Jun 17, 2016

In Brief

A Phase 3 clinical trial evaluating Intramuscular route of active treatment and Intravenous route of active treatment for Status Epilepticus. Completed, enrolled 1,023 participants across 17 sites.

Detailed Summary

The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStatus Epilepticus
CountriesUnited States
CollaboratorsMedical University of South Carolina, University of California, San Francisco, National Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2008
Enrollment StartJun 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.5 years ago

Interventions

Intramuscular route of active treatmentdrug

IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.

Intravenous route of active treatmentdrug

IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.