- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004297
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Daniel Lowenstein, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Seizures
- Status Epilepticus
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Neuromuscular Agents
- Muscle Relaxants, Central
- Diazepam
- Lorazepam
Other Study ID Numbers
- 199/11733
- UCSF-69020732504A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Status Epilepticus
-
Sohag UniversityCompletedStatus Epilepticus | Generalized Convulsive Status Epilepticus | Status Epilepticus, Generalized | Status Epilepticus, Generalized ConvulsiveEgypt
-
Marinus PharmaceuticalsCompletedEpilepsy | Status Epilepticus | Convulsive Status EPILEPTICUS | Non Convulsive Status EpilepticusUnited States
-
University of Southern DenmarkAarhus University Hospital; Copenhagen University Hospital, Denmark; University...RecruitingNon-Convulsive Status EpilepticusDenmark
-
Hospital Universitari de BellvitgeHospital Clinic of Barcelona; Institut d'Investigació Biomèdica de Girona Dr... and other collaboratorsCompletedGrand Mal Status Epilepticus | Non-convulsive Status EpilepticusSpain
-
University of Cape TownCompletedPediatric Status EpilepticusSouth Africa
-
University Hospital, MontpellierCompleted
-
University of VirginiaMedical University of South Carolina; National Institute of Neurological Disorders... and other collaboratorsCompletedBenzodiazepine Refractory Status EpilepticusUnited States
-
Xuanwu Hospital, BeijingUnknownGeneralized Convulsive Status EpilepticusChina
-
Assistance Publique - Hôpitaux de ParisCompletedStatus; Epilepticus, Tonic-clonicFrance
-
Xuanwu Hospital, BeijingRecruitingRefractory Status EpilepticusChina
Clinical Trials on lorazepam
-
Massachusetts General HospitalUCB PharmaWithdrawn
-
Johns Hopkins UniversitySociety of Family PlanningCompletedOral Sedation and Cervical Dilator PainUnited States
-
Mayo ClinicCompletedAlzheimer's Disease (AD)United States
-
Eunice Kennedy Shriver National Institute of Child...The Emmes Company, LLCCompleted
-
Laureate Institute for Brain Research, Inc.National Institute of Mental Health (NIMH); California Institute of TechnologyRecruitingDepression | Anxiety Disorders | Fear | Depression, Anxiety | Anxiety and Fear | Anxious DepressionUnited States
-
Merck Sharp & Dohme LLCCompleted
-
Northwell HealthWithdrawn
-
Mayo ClinicNational Institute of Mental Health (NIMH)Completed
-
Edgemont Pharmaceuticals, LLCCompletedGeneralized Anxiety Disorder (GAD)United States
-
St. Justine's HospitalCompleted