Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
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...
Brief Summary
Official Title: “Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: May 2003
Intervention(s) in this Clinical Trial
- Drug: Levetiracetam
Outcome Measures for this Clinical Trial
Primary Measures
- Adverse event rates, seizure counts and quality of life.
- Time Frame: 16 week treatment period
- Time Frame: 16 week treatment period
Criteria for Participation in this Clinical Trial
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
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 Investigator Information
Lead Investigator: UCB, Inc. Industry
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 February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643500
Study ID Number: N01033
ClinicalTrials.gov Identifier: NCT00643500
Health Authority: Spain: Spanish Agency of Medicines
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00643500
