Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy - Tabular View

Tracking Information

First Received Date ^ICMJE

February 21, 2008

Last Updated Date

September 14, 2009

Start Date ^ICMJE

January 2002

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adverse event rates, seizure counts and quality of life. [ Time Frame: 16 week treatment period ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00643500 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

Official Title ^ICMJE

Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

Brief Summary

Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study

to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development
to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded 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, Partial

Intervention ^ICMJE

Drug: Levetiracetam

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

342

Completion Date

May 2003

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male and female older than 16 years;
Epilepsy with partial onset seizures, with or without secondary generalization;
At least one concomitant marketed anti-epileptic drug

Exclusion Criteria:

Safety reasons

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

NCT00643500

Responsible Party

Study Director, UCB

Study ID Numbers ^ICMJE

N01033

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