NCT00114569

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

May 23, 2016

Status Verified

May 1, 2009

Enrollment Period

2.1 years

First QC Date

June 15, 2005

Last Update Submit

May 20, 2016

Conditions

Status Epilepticus

Keywords

childrenstatus epilepticuslorazepamsafetypharmacokineticsstatus epilepticus in children

Outcome Measures

Primary Outcomes (1)

  • Description of the pharmacokinetics of two different doses (0.05 and 0.1 mg/kg) IV lorazepam

Secondary Outcomes (1)

  • safety of IV lorazepam

Interventions

lorazepamDRUG

Eligibility Criteria

Age3 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Status Epilepticus

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • James Chamberlain, MD

    Children's National Medical Center, Washington, D.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

June 15, 2005

First Posted

June 16, 2005

Study Start

March 1, 2005

Primary Completion

April 1, 2007

Study Completion

February 1, 2009

Last Updated

May 23, 2016

Record last verified: 2009-05

Locations

US(1)