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Lorazepam for the Treatment of Status Epilepticus in Children
This study has been completed.
First Received: June 15, 2005   Last Updated: May 26, 2009   History of Changes
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00114569
  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 I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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
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: Children's National Medical Center ( James Chamberlain )
Study ID Numbers: HHSN275200403393C, HHSN275200403393C
Study First Received: June 15, 2005
Last Updated: May 26, 2009
ClinicalTrials.gov Identifier: NCT00114569     History of Changes
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:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Diseases
Central Nervous System Depressants
Brain Diseases
Pharmacologic Actions
Lorazepam
Autonomic Agents
Epilepsy
Status Epilepticus
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010