Status Epilepticus Clinical Trial
Official title:
Safety and Tolerability of Add-on Levetiracetam in Status Epilepticus
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | April 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Medical Centre Haaglanden | The Hague | South-Holland |
Lead Sponsor | Collaborator |
---|---|
Medical Center Haaglanden | UCB Pharma |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | o Uneventful intravenous (iv) administration of study medication | |||
Primary | o Toxicity profile on iv administration, including: | |||
Primary | § Irritation on injection site | |||
Primary | § Hypotension, defined as systolic blood pressure below 90 mm Hg recorded within 24 hours of the dose | |||
Primary | § Cardiac arrest (diagnosed clinically) or bradyarrhythmias including heart block, documented on an electrocardiogram | |||
Primary | § Respiratory depression, defined as the occurrence of apnea or need for intubation | |||
Primary | § Allergic reactions, like skin rash | |||
Primary | § Other side-effects | |||
Secondary | Pharmacokinetic parameters of levetiracetam and clonazepam in patients with SE |
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