Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs

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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

Who can participate

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 coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.

Exclusion criteria

Need for an additional AED.

Treatment and study plan

Levetiracetam

Drug

Primary outcomes

Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial.

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2005
First posted: Sep 8, 2005
Registry last updated: Nov 26, 2013

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