Status:
COMPLETED
Lorazepam for the Treatment of Status Epilepticus in Children
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
The Emmes Company, LLC
Conditions:
Status Epilepticus
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to gather the data to: 1) determine the best dose, and 2) evaluate its effectiveness and safety in stopping seizures. Part 1 is a pharmacokinetic study (study of how much ...
Detailed Description
Lorazepam is in a class of drugs called benzodiazepines that is used to treat seizures. Lorazepam has been widely used to treat children who have repeated or long seizures, a condition known as status...
Eligibility Criteria
Inclusion
- Generalized tonic clonic seizures within 1 hour OR 2 or more generalized tonic clonic seizures in rapid succession with no recovery of consciousness between seizures OR a single ongoing generalized tonic clonic seizure which has lasted at least 5 minutes
Exclusion
- Inability to obtain informed consent or assent
- Sustained hypotension
- Significant arrhythmia
- Known hypersensitivity to or contraindication to use of benzodiazepines
- Use of lorazepam within 4 days of study drug dosing
- American Association of Anesthesiology (ASA) Class \> 1
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00114569
Start Date
March 1 2005
End Date
February 1 2009
Last Update
May 23 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010