NCT00004297

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 1995

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1995

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2001

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Status Epilepticus

Keywords

epilepsyneurologic and psychiatric disordersrare diseaseseizuresstatus epilepticus

Interventions

diazepamDRUG
lorazepamDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

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Sponsors & Collaborators

MeSH Terms

Conditions

Status EpilepticusEpilepsyNeurologic ManifestationsMental DisordersRare DiseasesSeizures

Interventions

DiazepamLorazepam

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Daniel Lowenstein

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

November 1, 1995

Study Completion

February 1, 1999

Last Updated

June 24, 2005

Record last verified: 2001-12