S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development.

Completed

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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, whether or not secondarily generalized;
at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline;
using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.

Exclusion criteria

Presence of known pseudoseizures within the last year;
presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
on felbamate with less than 18 months exposure;
on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months;
uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

Treatment and study plan

Levetiracetam (Keppra)

Drug

Primary outcomes

Percentage reduction in seizure frequency.

Time frame: 16-week treatment period

Secondary outcomes

To further assess safety.
The patient-weighted Quality Of Life In Epilepsy inventory.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial Epilepsy

Important dates

Study start: 2000
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