Lorazepam for the Treatment of Status Epilepticus in Children

Completed · Phase 1

Conditions studied: Status Epilepticus

In brief

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).

Key facts

Study ID

NCT00114569

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

69

Starts

2005-03-01

Expected to finish

2009-02-01

Last updated by the study team

2016-05-23

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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