Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy

UCB

Status and phase

Completed

Phase 4

Conditions

Epilepsy

Treatments

Drug: Levetiracetam (Keppra)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00630357

N01037

Details and patient eligibility

About

A cohort of patients who became seizure-free during add-on treatment to one standard AED with Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was maintained. Tolerability was documented.

Enrollment

14 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of epilepsy with partial seizures;
having completed the trial N01031 of Keppra as adjunctive therapy (SKATE);
seizure-free over the last 3 months prior to protocol Visit 1;
1 concomitant marketed AED at the time of trial entry and throughout the previous trial N01031;
on the clinical judgment of the Investigator, progressive withdrawal of the concomitant AED and conversion to monotherapy with Keppra can be attempted.

Exclusion criteria

History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years;
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;
felbamate with less than 18 months exposure;
vigabatrin, without visual field assessment 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.