Pharmacovigilance Study of Keppra. SPAIN - SKATE : 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, Partial
Intervention: Levetiracetam (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 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.
Clinical Details
Official title: Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Adverse event rates, seizure counts and quality of life.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: January 2002
Ending date: May 2003
Last updated: March 25, 2008
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