Overview

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