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

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ClinicalTrials.gov Identifier: NCT00004297

Recruitment Status : Completed

First Posted : October 19, 1999

Last Update Posted : June 24, 2005

Sponsor:

Collaborator:

University of California, San Francisco

Information provided by:

Office of Rare Diseases (ORD)

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Status Epilepticus	Drug: diazepam Drug: lorazepam	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	210 participants
Allocation:	Randomized
Masking:	Double
Primary Purpose:	Treatment
Study Start Date :	November 1995
Study Completion Date :	February 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Diazepam Lorazepam

Genetic and Rare Diseases Information Center resources: Status Epilepticus

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004297

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

University of California, San Francisco

Investigators

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Study Chair:	Daniel Lowenstein	University of California, San Francisco

More Information

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ClinicalTrials.gov Identifier:	NCT00004297 History of Changes
Other Study ID Numbers:	199/11733 UCSF-69020732504A
First Posted:	October 19, 1999 Key Record Dates
Last Update Posted:	June 24, 2005
Last Verified:	December 2001

Keywords provided by Office of Rare Diseases (ORD):


epilepsy neurologic and psychiatric disorders rare disease seizures status epilepticus

Additional relevant MeSH terms:

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Lorazepam Status Epilepticus Seizures Neurologic Manifestations Nervous System Diseases Signs and Symptoms Diazepam Anticonvulsants Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Hypnotics and Sedatives	Central Nervous System Depressants Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Muscle Relaxants, Central Neuromuscular Agents Anesthetics, Intravenous Anesthetics, General Anesthetics

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