Lorazepam for the Treatment of Status Epilepticus in Children

NCT ID: NCT00114569

Last Updated: 2016-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2009-02-28

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.

Conditions

Status Epilepticus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

lorazepam

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Emmes Company, LLC

INDUSTRY

Sponsor Role: collaborator

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

NIH

Sponsor Role: lead

Responsible Party

Children's National Medical Center

Principal Investigators

James Chamberlain, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Children's National Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

HHSN275200403393C

Identifier Type: -

Identifier Source: secondary_id

HHSN275200403393C

Identifier Type: -

Identifier Source: org_study_id