Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

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

Completed

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Key information

Conditions

Epilepsy, Tonic-Clonic Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beroun, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Levetiracetam

Drug

Pharmaceutical form: oral tablets Route of administration: Oral use

Other names: Keppra

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).

Sponsors and collaborators

Lead sponsor

UCB Pharma SA

Industry

Registry information

Official study title

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.

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Sep 8, 2005
Registry last updated: Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed