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

• Status: Unknown status
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Center Haaglanden
• Collaborator: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

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