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

UCB

Status and phase: Completed; Phase 4

Conditions: Epilepsy, Partial

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643500

N01033

Details and patient eligibility

About

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.

Enrollment: 342 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)