Status EpilepticusPhase 1NCT00114569
Lorazepam for the Treatment of Status Epilepticus in Children
A Phase 1 study testing lorazepam in people with Status Epilepticus, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- lorazepam
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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).
Read the 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
- Being tested
- lorazepam
- Keywords
- children, status epilepticus, lorazepam, safety, pharmacokinetics, status epilepticus in children
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorazepamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam
Secondary outcomes (1)
safety of IV lorazepam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2005 (estimated)
- Study startMar 2005
- Primary completionApr 2007
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- The Emmes Company, LLC
- Investigators
- James Chamberlain, MD, Principal investigator, Children's National Medical Center, Washington, D.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114569
- Sponsor's protocol ID
- HHSN275200403393C
- Other IDs
- HHSN275200403393C
- Status last verified
- May 2009
- First submitted
- 15 Jun 2005
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Lorazepam for the Treatment of Status Epilepticus
- ClinicalTrials.gov ID
- NCT00114569
- Acronym / sponsor ID
- HHSN275200403393C
- Conditions
- Status Epilepticus
- Keywords
- children, status epilepticus, lorazepam, safety, pharmacokinetics, status epilepticus in children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- The Emmes Company, LLC
- Study start
- Mar 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lorazepam | Drug | – |
Primary outcome
Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam
1 secondary outcome
safety of IV lorazepam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Chamberlain, MD principal investigator
Children's National Medical Center, Washington, D.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lorazepam in people with Status Epilepticus, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.