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

Tracking Information

First Received Date ^ICMJE

February 27, 2008

Last Updated Date

September 14, 2009

Start Date ^ICMJE

March 2003

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and the tolerability of Keppra in a broad population of patients.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00631150 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Obtain further information about optimal daily dose.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: Levetiracetam (Keppra)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2004

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00631150

Responsible Party

Study Director, UCB

Study ID Numbers ^ICMJE

N01035

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

Information Provided By

UCB, Inc.

Verification Date

September 2009

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