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

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ClinicalTrials.gov Identifier: NCT00160628
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 26, 2013
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Epilepsy, Partial Drug: Levetiracetam Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official 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
Study Start Date : March 2004
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004





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

Secondary Outcome Measures :
  1. To assess safety of levetiracetam


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160628


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma

Additional Information:
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00160628     History of Changes
Other Study ID Numbers: N01099
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: February 2010
Keywords provided by UCB Pharma:
Epilepsy
Partial Onset Seizures
Keppra
Levetiracetam
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents