Status EpilepticusPhase 3NCT00004297
Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus
A Phase 3 study testing diazepam and lorazepam in people with Status Epilepticus, run by National Institute of Neurological Disorders and Stroke (NINDS).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- diazepam and lorazepam
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Nov 1995to Feb 1999
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
About this study
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.
Read the 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.
- Conditions
- Status Epilepticus
- Being tested
- diazepam, lorazepam
- Keywords
- epilepsy, neurologic and psychiatric disorders, rare disease, seizures, status epilepticus
- Medical subject headings
- Status Epilepticus, Epilepsy, Neurologic Manifestations, Mental Disorders, Rare Diseases, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diazepamDrug
lorazepamDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startNov 1995
- Study completionFeb 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of California, San Francisco
- Investigators
- Daniel Lowenstein, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004297
- Sponsor's protocol ID
- 199/11733
- Other IDs
- UCSF-69020732504A
- Status last verified
- Dec 2001
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No