Status:

UNKNOWN

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

Lead Sponsor:

Medical Center Haaglanden

Collaborating Sponsors:

UCB Pharma

Conditions:

Status Epilepticus

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 patient...

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 th...

Eligibility Criteria

Inclusion

  • 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

  • Woman \< 50 years of age, without information on pregnancy
  • Known pregnancy
  • Known allergy for levetiracetam
  • Daily dose levetiracetam of more than 2000mg/day

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

End Date :

April 1 2008

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT00362141

Start Date

October 1 2006

End Date

April 1 2008

Last Update

April 2 2007

Active Locations (1)

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1

Medical Centre Haaglanden

The Hague, South Holland, Netherlands, 2512VA