NCT00004297

Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (planned)
• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and complications of diazepam and lorazepam given intravenously as prehospital therapy to patients in status epilepticus. II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the subsequent emergency department admission. III. Establish whether prehospital therapy alters hospital management of these patients and ultimately affects patient outcome.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by center. Patients en route to the hospital in a San Francisco Department of Health Paramedic Division ambulance are randomly assigned to 1 of 3 treatment groups. Informed consent is waived due to impaired consciousness. Patients receive intravenous diazepam, lorazepam, or placebo during transport. The patient is re-treated if the seizure is sustained after the first dose or recurs after the first dose without the patient regaining consciousness. Upon arrival at the hospital, all patients receive the standard status epilepticus treatment in use at that site.

Conditions

• Status Epilepticus

Interventions

Type	Name	Description
DRUG	diazepam
DRUG	lorazepam

Timeline

• Start date: 1995-11-01
• Completion: 1999-02-01
• First posted: 1999-10-19
• Last updated: 2005-06-24