Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Status Epilepticus
Intervention: diazepam (Drug); lorazepam (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS) Official(s) and/or principal investigator(s):
Daniel Lowenstein, Study Chair, Affiliation: University of California, San Francisco
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics-- Status epilepticus with at least 5 minutes of sustained seizure
activity with a depressed level of consciousness, or 2 or more discrete seizures without
recovery or consciousness between seizures Verified by bystander or observed by paramedic
from San Francisco Department of Health - -Prior/Concurrent Therapy-- No chronic benzodiazepines for seizure disorder - -Patient Characteristics-- Cardiovascular: Systolic
blood pressure at least 100 mm Hg No second- or third- degree atrioventricular block No
sustained ectopic tachyrhythmia Pulse rate between 60 and 150 No severe myocardial
insufficiency No hypovolemic, cardiogenic, or obstructive shock Pulmonary: No history of
asthma No history of chronic obstructive airway disease No history of limited pulmonary
reserve Other: No allergy or prior sensitivity to benzodiazepines No distributive shock
(e. g., septic, neurogenic, or anaphylactic)
Locations and Contacts
Additional Information
Starting date: November 1995
Ending date: February 1999
Last updated: June 23, 2005
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