Status Epilepticus | Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus
Status Epilepticus research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2006
Completed Date: April 2008
Phase: Phase 2
Primary Outcome: o Uneventful intravenous (iv) administration of study medication
Secondary Outcome: Pharmacokinetic parameters of levetiracetam and clonazepam in patients with SE
Study sponsors, principal investigator, and references
Principal Investigator: Charles Vecht, MD, PhD
Lead Sponsor: Medical Center Haaglanden
Collaborator: UCB Pharma