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

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ClinicalTrials.gov Identifier: NCT00160654
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 15, 2013
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:

Community based study assessing safety and efficacy of levetiracetam in partial onset seizures.

The optimal dose in daily clinical practice will be used.


Condition or disease Intervention/treatment Phase
Epilepsy, Partial Drug: Levetiracetam Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 345 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase IV, Open-label, Multi-center, Community-based Trial Studying the Safety and Efficacy of Keppra™ as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy.
Study Start Date : November 2003
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006





Primary Outcome Measures :
  1. To assess safety of levetiracetam

Secondary Outcome Measures :
  1. To evaluate efficacy of levetiracetam in community based practice.


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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 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): NCT00160654


Locations
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Hong Kong
Hong Kong, Hong Kong
Kwun Tong (Kowloon), Hong Kong
Malaysia
Kuala Llumpur, Malaysia
Penang, Malaysia
Philippines
Manila, Philippines
Quezon, Philippines
Singapore
Singapore, Singapore
Taiwan
Changua, Taiwan
Hualien, Taiwan
Kaohsiung County, Taiwan
Kaohsiung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan County, Taiwan
Thailand
Bangkok, Thailand
Chiangmai, Thailand
Khon Kaen, Thailand
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: NCT00160654     History of Changes
Other Study ID Numbers: N01036
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: July 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