Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
Overview[ - collapse ][ - ]
| Purpose | 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 | Status Epilepticus |
| Intervention | Drug: diazepam Drug: lorazepam |
| Phase | Phase 3 |
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Responsible Party | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier | NCT00004297 |
| First Received | October 18, 1999 |
| Last Updated | June 23, 2005 |
| Last verified | December 2001 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 18, 1999 |
|---|---|
| Last Updated Date | June 23, 2005 |
| Start Date | November 1995 |
| Estimated Primary Completion Date | February 1999 |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus |
|---|---|
| Official Title | Not Provided |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Status Epilepticus |
| Intervention | Drug: diazepam Drug: lorazepam |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 210 |
| Estimated Completion Date | February 1999 |
| Estimated Primary Completion Date | Not Provided |
| 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) |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00004297 |
|---|---|
| Other Study ID Numbers | 199/11733 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Office of Rare Diseases (ORD) |
| Study Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Collaborators | University of California, San Francisco |
| Investigators | Study Chair: Daniel Lowenstein University of California, San Francisco |
| Verification Date | December 2001 |