Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.
- Registration Number
- NCT00150813
- Lead Sponsor
- UCB Pharma SA
- Brief Summary
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- Subjects with a confirmed diagnosis of epilepsy.
- Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
- Subjects having participated in the previous double-blind monotherapy trial (N01061 [NCT00150735] or N01093 [NCT00150787]).
- Male/female subjects (>= 16 years).
Exclusion Criteria
- Need for an additional Antiepileptic Drug (AED).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Levetiracetam Levetiracetam Subjects received open-label Levetiracetam.
- Primary Outcome Measures
Name Time Method Percentage Participants With Treatment Emergent Adverse Events From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
- Secondary Outcome Measures
Name Time Method