Lorazepam for the Treatment of Status Epilepticus in Children
Overview[ - collapse ][ - ]
| 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). |
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| Condition | Status Epilepticus |
| Intervention | Drug: lorazepam |
| Phase | Phase 1 |
| Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Responsible Party | 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 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 15, 2005 |
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| Last Updated Date | February 13, 2011 |
| Start Date | March 2005 |
| Estimated Primary Completion Date | February 2009 |
| Current Primary Outcome Measures | Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam |
| Current Secondary Outcome Measures | safety of IV lorazepam |
Descriptive Information[ + expand ][ + ]
| Brief Title | Lorazepam for the Treatment of Status Epilepticus in Children |
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| Official Title | Use of Lorazepam for the Treatment of Status Epilepticus |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Status Epilepticus |
| Intervention | Drug: lorazepam |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
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| Estimated Enrollment | 69 |
| Estimated Completion Date | February 2009 |
| Estimated Primary Completion Date | April 2007 |
| 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 |
| Gender | Both |
| Ages | 3 Months |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00114569 |
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| Other Study ID Numbers | HHSN275200403393C |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Study Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: James Chamberlain, MD Children's National Medical Center, Washington, D.C. |
| Verification Date | May 2009 |
Locations[ + expand ][ + ]
| Children's National Medical Center | Washington, District of Columbia, United States, 20010 |
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