Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Medical Center Haaglanden.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Medical Center Haaglanden
ClinicalTrials.gov Identifier:
NCT00362141
First received: August 8, 2006
Last updated: March 30, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Status Epilepticus
Drug: levetiracetam (add-on)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Add-on Levetiracetam in Status Epilepticus

Resource links provided by NLM:


Further study details as provided by Medical Center Haaglanden:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Pharmacokinetic parameters of levetiracetam and clonazepam in patients with SE

Estimated Enrollment: 12
Study Start Date: October 2006
Estimated Study Completion Date: April 2008
Detailed Description:

Status epilepticus (SE) is a disorder with high mortality and morbidity. There are strong indications that ongoing seizure activity substantially reduces the chances on a good outcome. This implies that optimal treatment of SE should start as soon as possible. Unfortunately, treatment options are limited and often based on little evidence. Besides, current treatment options are hampered by serious side-effects like respiratory depression and impaired consciousness. Therefore, the advent of new and effective anti-epileptic drugs (AEDs) is of great potential interest for the treatment of SE. Presently, the newer AEDs are mainly used in later stages of SE at a time when the disease is often more difficult to control. The characteristics of one of these recently introduced anticonvulsants i.e. levetiracetam seems to provide a number of fortunate properties for application as first-line treatment of SE. The complicating side-effects of “classical” AEDs, like a decrease in cardiorespiratory function or in level of consciousness are hardly present. Besides, levetiracetam may lower the need for benzodiazepines, reducing chances on respiratory depression by benzodiazepines at higher doses. Due to a remarkable synergism with first-line administered benzodiazepines, levetiracetam may therefore reduce the need for intubation or ICU treatment. Besides, it may enhance the immediate cessation of seizures, prolong the anti-seizure activity of benzodiazepines and provide neuroprotective properties. The sustained efficacy of levetiracetam would suggest that long term sequelae secondary to neurological damage, may also be reduced. Levetiracetam IV has recently been shown to be safe in healthy volunteers, and becomes available for iv application in clinical practice, early 2006. To date, there are hardly any data available on its applicability in medical emergencies like SE. We propose as a first step the executing of a phase II study on tolerability and safety of intravenous levetiracetam in patients with SE. Current first-line treatment of SE consists of standardized administration of benzodiazepines. For the study we propose to apply this regimen together with the iv administration of levetiracetam as add-on therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Woman < 50 years of age, without information on pregnancy
  • Known pregnancy
  • Known allergy for levetiracetam
  • Daily dose levetiracetam of more than 2000mg/day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362141

Contacts
Contact: Charles Vecht, MD +31-70-3302508 c.vecht@mchaaglanden.nl
Contact: Joris Uges, Pharmacist +31-70-3217217 j.uges@mchaaglanden.nl

Locations
Netherlands
Medical Centre Haaglanden Recruiting
The Hague, South-Holland, Netherlands, 2512VA
Contact: Joris Uges, Pharmacist    +31-70-3217217    j.uges@mchaaglanden.nl   
Contact: Erik Wilms, Pharm D    +31-70-3303131    e.wilms@mchaaglanden.nl   
Principal Investigator: Charles Vecht, MD, PhD         
Sponsors and Collaborators
Medical Center Haaglanden
UCB, Inc.
Investigators
Principal Investigator: Charles Vecht, MD, PhD Medical Centre Haaglanden
  More Information

Additional Information:
CCMO  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00362141     History of Changes
Other Study ID Numbers: 06-013, METC 06-013
Study First Received: August 8, 2006
Last Updated: March 30, 2007
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Medical Center Haaglanden:
levetiracetam
status
epilepticus

Additional relevant MeSH terms:
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014