Back to resultsPharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
Primary Purpose
Epilepsy, Partial
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy, Partial focused on measuring Levetiracetam, Keppra
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Adverse event rates, seizure counts and quality of life.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00643500
Brief Title
Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
Official Title
Pharmacovigilance Study of Keppra. SPAIN - SKATE : 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
January 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial
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
342 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Primary Outcome Measure Information:
Title
Adverse event rates, seizure counts and quality of life.
Time Frame
16 week treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
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