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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

diazepam

lorazepam

About this trial

This is an interventional treatment trial for Status Epilepticus focused on measuring epilepsy, neurologic and psychiatric disorders, rare disease, seizures, status epilepticus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004297

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT00004297

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2001

Overall Recruitment Status

Completed

Study Start Date

November 1995 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 1999 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators

University of California, San Francisco

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Status Epilepticus

Keywords

epilepsy, neurologic and psychiatric disorders, rare disease, seizures, status epilepticus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

Double

Allocation

Randomized

Enrollment

210 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

diazepam

Intervention Type

Drug

Intervention Name(s)

lorazepam

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Lowenstein

Organizational Affiliation

University of California, San Francisco

Official's Role

Study Chair

Status Epilepticus

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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