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

November 14, 2013 updated by: UCB Pharma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

February 21, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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