Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004297
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSF-69020732504A | None | None | None |