A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

UCB Pharma35 enrolled

Overview

Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

Levetiracetam (Keppra)DRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * partial onset seizures with or without secondary generalisation with epilepsy. Exclusion Criteria: * hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.

Outcomes

Primary Outcomes

Safety and the tolerability of Keppra in a broad population of patients.

Secondary Outcomes

Obtain further information about optimal daily dose.

Data from ClinicalTrials.gov

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