Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

Phase 3CompletedNCT00150813

UCB Pharma SA66 enrolled

Overview

An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy, Tonic-clonic

Interventions

LevetiracetamDRUG

Pharmaceutical form: oral tablets Route of administration: Oral use

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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).

Locations (21)

Unnamed facility

Beroun, Czechia

Unnamed facility

Brno, Czechia

Unnamed facility

České Budějovice, Czechia

Outcomes

Primary Outcomes

Percentage Participants With Treatment Emergent Adverse Events

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).

Time frame: From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks

Data from ClinicalTrials.gov

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