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...
Date First Received: February 27, 2008
Last Updated: March 6, 2008
Verified by: UCB, February 2008
Clinical Trial Phase: Phase 4 | Start Date: March 2003
Overall Status: Completed
Estimated Enrollment: 35
Brief Summary
Official Title: “A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Study Primary Completion Date: July 2004
Intervention(s) in this Clinical Trial
- Drug: Levetiracetam (Keppra)
Outcome Measures for this Clinical Trial
Primary Measures
- Safety and the tolerability of Keppra in a broad population of patients.
Secondary Measures
- Obtain further information about optimal daily dose.
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 16 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00631150
Study ID Number: N01035
ClinicalTrials.gov Identifier: NCT00631150
Health Authority: Greece: National Organization of Medicines
Clinical Trials Authorship and Review
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