Lorazepam for the Treatment of Status Epilepticus in Children

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborators: The Emmes Company, LLC; The EMMES Corporation
• Treatments: Lorazepam

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