A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Levetiracetam (Keppra) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
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.
Clinical Details
Official title: A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Safety and the tolerability of Keppra in a broad population of patients.
Secondary outcome: Obtain further information about optimal daily dose.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: March 2003
Ending date: July 2004
Last updated: March 6, 2008
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