Status:
COMPLETED
Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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. Tolera...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00630357
Start Date
March 1 2003
End Date
July 1 2004
Last Update
November 15 2013
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