A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
November 14, 2013 updated by: UCB Pharma
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
35
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 (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety and the tolerability of Keppra in a broad population of patients.
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Secondary Outcome Measures
Outcome Measure |
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Obtain further information about optimal daily dose.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 2003
Primary Completion (ACTUAL)
July 1, 2004
Study Completion (ACTUAL)
July 1, 2004
Study Registration Dates
First Submitted
February 27, 2008
First Submitted That Met QC Criteria
March 6, 2008
First Posted (ESTIMATE)
March 7, 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
- N01035
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.