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OpenTrials
Completed

NCT Number: NCT00160628

Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy

A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy.

Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.

Completed

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Key information

Conditions

Epilepsy, Partial Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

18 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 epilepsy experiencing partial seizures, whether or not secondarily generalized.
  • Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
  • Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.

Exclusion criteria

  • Subjects on felbamate with less than 18 months exposure.
  • Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
  • Presence of known pseudoseizures within the last year.
  • Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
  • Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Treatment and study plan

Levetiracetam

Drug

Primary outcomes

  1. To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).

Secondary outcomes

  1. To assess safety of levetiracetam

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Levetiracetam as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy for Bridging Purpose With a Similar Study on Caucasian Epileptic Subjects

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Sep 12, 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.

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