- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00114569
Lorazepam for the Treatment of Status Epilepticus in Children
May 20, 2016 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Use of Lorazepam for the Treatment of Status Epilepticus
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).
Study Overview
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
Interventional
Enrollment (Actual)
69
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Children's National Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam
|
Secondary Outcome Measures
Outcome Measure |
---|
safety of IV lorazepam
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: James Chamberlain, MD, Children's National Medical Center, Washington, D.C.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
June 15, 2005
First Submitted That Met QC Criteria
June 15, 2005
First Posted (Estimate)
June 16, 2005
Study Record Updates
Last Update Posted (Estimate)
May 23, 2016
Last Update Submitted That Met QC Criteria
May 20, 2016
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Seizures
- Status Epilepticus
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Lorazepam
Other Study ID Numbers
- HHSN275200403393C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Status Epilepticus
-
Sohag UniversityCompletedStatus Epilepticus | Generalized Convulsive Status Epilepticus | Status Epilepticus, Generalized | Status Epilepticus, Generalized ConvulsiveEgypt
-
Marinus PharmaceuticalsCompletedEpilepsy | Status Epilepticus | Convulsive Status EPILEPTICUS | Non Convulsive Status EpilepticusUnited States
-
University of Southern DenmarkAarhus University Hospital; Copenhagen University Hospital, Denmark; University...RecruitingNon-Convulsive Status EpilepticusDenmark
-
Hospital Universitari de BellvitgeHospital Clinic of Barcelona; Institut d'Investigació Biomèdica de Girona Dr... and other collaboratorsCompletedGrand Mal Status Epilepticus | Non-convulsive Status EpilepticusSpain
-
University Hospital, MontpellierCompleted
-
University of Cape TownCompletedPediatric Status EpilepticusSouth Africa
-
Xuanwu Hospital, BeijingRecruitingRefractory Status EpilepticusChina
-
Assiut UniversityNot yet recruitingConvulsive Status EPILEPTICUS
-
Yale UniversityRecruitingStatus Epilepticus | Refractory Status EpilepticusUnited States
-
Marinus PharmaceuticalsNot yet recruitingRefractory Status EpilepticusSpain, Switzerland, Germany, France, Austria, Italy, United Kingdom, Czechia, Croatia, Finland, Belgium, Lithuania, Hungary, Israel, Denmark
Clinical Trials on lorazepam
-
Massachusetts General HospitalUCB PharmaWithdrawn
-
Johns Hopkins UniversitySociety of Family PlanningCompletedOral Sedation and Cervical Dilator PainUnited States
-
Mayo ClinicCompletedAlzheimer's Disease (AD)United States
-
Laureate Institute for Brain Research, Inc.National Institute of Mental Health (NIMH); California Institute of TechnologyRecruitingDepression | Anxiety Disorders | Fear | Depression, Anxiety | Anxiety and Fear | Anxious DepressionUnited States
-
Merck Sharp & Dohme LLCCompleted
-
Northwell HealthWithdrawn
-
Mayo ClinicNational Institute of Mental Health (NIMH)Completed
-
Edgemont Pharmaceuticals, LLCCompletedGeneralized Anxiety Disorder (GAD)United States
-
St. Justine's HospitalCompleted
-
Kamuzu University of Health SciencesCompletedStatus Epilepticus | ConvulsionsMalawi