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
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.