Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114569
Status:
COMPLETED
Last Update Posted:
2016-05-23
First Post:
2005-06-15
Brief Title:
Lorazepam for the Treatment of Status Epilepticus in Children
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Use of Lorazepam for the Treatment of Status Epilepticus
Status:
COMPLETED
Status Verified Date:
2009-05
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:
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 drug is found in the body after it is given through a vein and how fast the body gets rid of the drug
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 epilepticus SE However lorazepam is not currently approved by the FDA for use in children under 18 years of age Therefore the purpose of this study is to gather the data needed for FDA approval Specifically we will 1 determine the best dose and 2 evaluate its effectiveness and safety in stopping seizures Part 1 is a pharmacokinetic study These are studies designed to identify and describe one or more of the following basic pharmacological concepts in humans absorption ie how much gets into the body distribution ie where it goes in the body and metabolism and elimination ie how the body gets rid of the medication and how long it takes The study procedures involve taking blood samples from children taking their vital signs and conducting physical examinations Informed consent will be obtained from all participants as required by federal guidelines Patients will be divided into two groups The first group will be patients who present to one of the 10 participating Emergency Rooms ERs in status epilepticus repeated or continuous seizures We will either ask for consent in the ER or if we know they have a seizure disorder and have frequent visits to the ER consent them beforehand for future visits to the ER The second group will include patients who have a known seizure disorder and agree to be electively admitted to the hospital for a dose of lorazepam when they are not having seizures We will draw blood samples from patients for up to 48 hours and then follow up via telephone for 30 days from the day the medication was given to assess for side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSN275200403393C | None | None | None |