Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
Phase 4
Completed
- Conditions
- Epilepsy, Partial
- Registration Number
- NCT00643500
- Lead Sponsor
- UCB Pharma
- Brief Summary
Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study
* to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development
* to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 342
Inclusion Criteria
- Male and female older than 16 years;
- Epilepsy with partial onset seizures, with or without secondary generalization;
- At least one concomitant marketed anti-epileptic drug
Exclusion Criteria
- Safety reasons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse event rates, seizure counts and quality of life. 16 week treatment period
- Secondary Outcome Measures
Name Time Method