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Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
This study has been completed.
Study NCT00004297   Information provided by Office of Rare Diseases (ORD)
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes

October 18, 1999
June 23, 2005
November 1995
 
 
 
Complete list of historical versions of study NCT00004297 on ClinicalTrials.gov Archive Site
 
 
 
Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
 

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.

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.

Phase III
Interventional
Treatment, Randomized, Double-Blind
Status Epilepticus
  • Drug: diazepam
  • Drug: lorazepam
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
210
February 1999
 

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)

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00004297
 
199/11733, UCSF-69020732504A
National Institute of Neurological Disorders and Stroke (NINDS)
University of California, San Francisco
Study Chair: Daniel Lowenstein University of California, San Francisco
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP