Lorazepam for the Treatment of Status Epilepticus in Children

This study has been completed.

Sponsor:

Information provided by:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ClinicalTrials.gov Identifier:

NCT00114569

First received: June 15, 2005

Last updated: February 13, 2011

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 15, 2005

Last Updated Date

February 13, 2011

Start Date ^ICMJE

March 2005

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00114569 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

safety of IV lorazepam

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lorazepam for the Treatment of Status Epilepticus in Children

Official Title ^ICMJE

Use of Lorazepam for the Treatment of Status Epilepticus

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 (i.e. how much gets into the body); distribution (i.e. where it goes in the body); and metabolism and elimination (i.e. 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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Status Epilepticus

Intervention ^ICMJE

Drug: lorazepam

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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 Criteria:

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

Gender

Both

Ages

3 Months to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00114569

Other Study ID Numbers ^ICMJE

HHSN275200403393C, HHSN275200403393C

Has Data Monitoring Committee

Yes

Responsible Party

James Chamberlain, Children's National Medical Center

Study Sponsor ^ICMJE

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

James Chamberlain, MD

Children's National Medical Center, Washington, D.C.

Information Provided By

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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