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A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00631150
First Posted: March 7, 2008
Last Update Posted: November 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UCB Pharma
February 27, 2008
March 7, 2008
November 15, 2013
March 2003
July 2004   (Final data collection date for primary outcome measure)
Safety and the tolerability of Keppra in a broad population of patients.
Same as current
Complete list of historical versions of study NCT00631150 on ClinicalTrials.gov Archive Site
Obtain further information about optimal daily dose.
Same as current
Not Provided
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A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Epilepsy
Drug: Levetiracetam (Keppra)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
July 2004
July 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • partial onset seizures with or without secondary generalisation with epilepsy.

Exclusion Criteria:

  • hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00631150
N01035
No
Not Provided
Not Provided
Study Director, UCB
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP