Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Etiracetam; Levetiracetam

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