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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?

Status Epilepticus

Study Interventions

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.

Drug:levetiracetam (add-on)

Study Arms

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.

Study Status

Unknown status

Start Date: October 2006

Completed Date: April 2008

Phase: Phase 2

Type: Interventional

Design:

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

More information:https://clinicaltrials.gov/show/NCT00362141

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