S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Phase 4
Completed
- Conditions
- Epilepsy
- Registration Number
- NCT00630968
- Lead Sponsor
- UCB Pharma
- Brief Summary
The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1541
Inclusion Criteria
- Partial onset seizures, whether or not secondarily generalized;
- at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline;
- using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.
Exclusion Criteria
- 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;
- on felbamate with less than 18 months exposure;
- on vigabatrin, but visual field had not been assessed 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 Percentage reduction in seizure frequency. 16-week treatment period
- Secondary Outcome Measures
Name Time Method To further assess safety. The patient-weighted Quality Of Life In Epilepsy inventory.