A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures
Phase 2
Withdrawn
- Conditions
- Epilepsies, Partial
- Registration Number
- NCT00422110
- Lead Sponsor
- UCB Pharma
- Brief Summary
This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Subjects from 16 to 70 years old
- Confirmed diagnosis of focal epilepsy
- Partial seizures uncontrolled while taking 1 or 2 AEDs
- At least 8 partial seizures during the 8-week baseline period
Exclusion Criteria
- Seizures occurring only in clusters
- Status epilepticus within 1 year
- Progressive CNS disorder
- Other serious or uncontrolled diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluate the efficacy of seletracetam compared to placebo in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite treatment with 1 - 2 concomittant AEDs
- Secondary Outcome Measures
Name Time Method Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)