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| 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: | 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 |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| Principal Investigator: | James Chamberlain, MD | Children's National Medical Center, Washington, D.C. |
More Information
| 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 |
|
children status epilepticus lorazepam |
safety pharmacokinetics status epilepticus in children |
|
Status Epilepticus Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Lorazepam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Hypnotics and Sedatives Central Nervous System Depressants |
Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |