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

UCB

Status and phase

Completed

Phase 4

Conditions

Epilepsy

Treatments

Drug: Levetiracetam (Keppra)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00630968

N01031

Details and patient eligibility

About

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.

Enrollment

1,541 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.