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

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

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.