Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus
Primary Purpose
Status Epilepticus
Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
levetiracetam (add-on)
Sponsored by
About this trial
This is an interventional treatment trial for Status Epilepticus focused on measuring levetiracetam, status, epilepticus
Eligibility 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
Sites / Locations
- Medical Centre HaaglandenRecruiting
Outcomes
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
Full Information
NCT ID
NCT00362141
First Posted
August 8, 2006
Last Updated
March 30, 2007
Sponsor
Medical Center Haaglanden
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00362141
Brief Title
Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus
Official Title
Safety and Tolerability of Add-on Levetiracetam in Status Epilepticus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Medical Center Haaglanden
Collaborators
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus
Keywords
levetiracetam, status, epilepticus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
levetiracetam (add-on)
Primary Outcome Measure Information:
Title
o Uneventful intravenous (iv) administration of study medication
Title
o Toxicity profile on iv administration, including:
Title
§ Irritation on injection site
Title
§ Hypotension, defined as systolic blood pressure below 90 mm Hg recorded within 24 hours of the dose
Title
§ Cardiac arrest (diagnosed clinically) or bradyarrhythmias including heart block, documented on an electrocardiogram
Title
§ Respiratory depression, defined as the occurrence of apnea or need for intubation
Title
§ Allergic reactions, like skin rash
Title
§ Other side-effects
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters of levetiracetam and clonazepam in patients with SE
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Vecht, MD
Phone
+31-70-3302508
Email
c.vecht@mchaaglanden.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Joris Uges, Pharmacist
Phone
+31-70-3217217
Email
j.uges@mchaaglanden.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Vecht, MD, PhD
Organizational Affiliation
Medical Centre Haaglanden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Centre Haaglanden
City
The Hague
State/Province
South-Holland
ZIP/Postal Code
2512VA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joris Uges, Pharmacist
Phone
+31-70-3217217
Email
j.uges@mchaaglanden.nl
First Name & Middle Initial & Last Name & Degree
Erik Wilms, Pharm D
Phone
+31-70-3303131
Email
e.wilms@mchaaglanden.nl
First Name & Middle Initial & Last Name & Degree
Charles Vecht, MD, PhD
12. IPD Sharing Statement
Links:
URL
http://www.ccmo-online.nl
Description
CCMO
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Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus
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