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
  Purpose

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).


Condition Intervention Phase
Status Epilepticus
Drug: lorazepam
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Lorazepam for the Treatment of Status Epilepticus

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam

Secondary Outcome Measures:
  • safety of IV lorazepam

Enrollment: 69
Study Start Date: March 2005
Study Completion Date: February 2009
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114569

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Investigators
Principal Investigator: James Chamberlain, MD Children's National Medical Center, Washington, D.C.
  More Information

No publications provided

Responsible Party: James Chamberlain, Children's National Medical Center
ClinicalTrials.gov Identifier: NCT00114569     History of Changes
Other Study ID Numbers: HHSN275200403393C, HHSN275200403393C
Study First Received: June 15, 2005
Last Updated: February 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
children
status epilepticus
lorazepam
safety
pharmacokinetics
status epilepticus in children

Additional relevant MeSH terms:
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014