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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levetiracetam (Keppra)

Drug

Primary outcomes

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

Secondary outcomes

Obtain further information about optimal daily dose.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Mar 7, 2008
Registry last updated: Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed