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Lorazepam for the Treatment of Status Epilepticus in Children

NCT00114569 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2016-05-23

No results posted yet for this study

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).

Conditions

  • Status Epilepticus

Interventions

DRUG

lorazepam

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

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

    lead NIH

Principal Investigators

  • James Chamberlain, MD · Children's National Medical Center, Washington, D.C.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2007-04-30
Completion
2009-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00114569 on ClinicalTrials.gov