Back to resultsA Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levetiracetam (Keppra)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Levetiracetam, Keppra
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Safety and the tolerability of Keppra in a broad population of patients.
Secondary Outcome Measures
Obtain further information about optimal daily dose.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00631150
Brief Title
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Official Title
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Levetiracetam, Keppra
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam (Keppra)
Primary Outcome Measure Information:
Title
Safety and the tolerability of Keppra in a broad population of patients.
Secondary Outcome Measure Information:
Title
Obtain further information about optimal daily dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
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