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

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UCB

Status and phase

Completed
Phase 3

Conditions

Epilepsy, Partial

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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