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

Phase 4

Completed

• Conditions: Epilepsy

• Registration Number: NCT00630357
• Lead Sponsor: UCB Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-07
• Study Completion: 2004-07
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Status Verified: 2009-09
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Investigate seizure freedom with Keppra flexible dose.

Secondary Outcome Measures

Name	Time	Method
Tolerability and safety.