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

UCB Pharma342 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

342

Conditions

Epilepsy, Partial

Interventions

LevetiracetamDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adverse event rates, seizure counts and quality of life.

Time frame: 16 week treatment period

Data from ClinicalTrials.gov

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