A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From the N01061 or the N01093 Trials.
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- UCB Pharma SA
- Enrollment
- 66
- Primary Endpoint
- Percentage Participants With Treatment Emergent Adverse Events
Overview
Brief Summary
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Levetiracetam
Subjects received open-label Levetiracetam.
Intervention: Levetiracetam (Drug)
Outcomes
Primary Outcomes
Percentage Participants With Treatment Emergent Adverse Events
Time Frame: 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 Outcomes
No secondary outcomes reported