NCT00362141

Brief Summary

The purpose of this study is to determine whether levetiracetam is safe and well tolerated by patients while suffering a status epilepticus. Levetiracetam is added to the standard treatment of patients with this disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 2, 2007

Status Verified

March 1, 2007

First QC Date

August 8, 2006

Last Update Submit

March 30, 2007

Conditions

Status Epilepticus

Keywords

levetiracetamstatusepilepticus

Outcome Measures

Primary Outcomes (8)

  • o Uneventful intravenous (iv) administration of study medication

  • o Toxicity profile on iv administration, including:

  • § Irritation on injection site

  • § Hypotension, defined as systolic blood pressure below 90 mm Hg recorded within 24 hours of the dose

  • § Cardiac arrest (diagnosed clinically) or bradyarrhythmias including heart block, documented on an electrocardiogram

  • § Respiratory depression, defined as the occurrence of apnea or need for intubation

  • § Allergic reactions, like skin rash

  • § Other side-effects

Secondary Outcomes (1)

  • Pharmacokinetic parameters of levetiracetam and clonazepam in patients with SE

Interventions

levetiracetam (add-on)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: ≥18 years of age
  • All types of SE, diagnosed by the medical examiner according to the predefined definition. Absence SE has to be confirmed by EEG.
  • Woman: 18-50 years of age of whom is known, from anamnesis or hetero-anamnesis (first line relative), that she is not pregnant.

You may not qualify if:

  • Woman \< 50 years of age, without information on pregnancy
  • Known pregnancy
  • Known allergy for levetiracetam
  • Daily dose levetiracetam of more than 2000mg/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Centre Haaglanden

The Hague, South Holland, 2512VA, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

Status Epilepticus

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Charles Vecht, MD, PhD

    Medical Centre Haaglanden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Vecht, MD

CONTACT

+31-70-3302508c.vecht@mchaaglanden.nl

Joris Uges, Pharmacist

CONTACT

+31-70-3217217j.uges@mchaaglanden.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 9, 2006

Study Start

October 1, 2006

Study Completion

April 1, 2008

Last Updated

April 2, 2007

Record last verified: 2007-03

Locations

NL(1)