Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
NCT ID: NCT00152516
Last Updated: 2013-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
255 participants
INTERVENTIONAL
2004-10-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Levetiracetam
levetiracetam (LEV)
Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
Interventions
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levetiracetam (LEV)
Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Seizures too close together to accurately count
* Pseudoseizures
* Status epilepticus 1 month prior Visit 1
* Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.
1 Month
16 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493
Locations
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Mobile, Alabama, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Bradenton, Florida, United States
Loxahatchee Groves, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Saint Paul, Minnesota, United States
Lebanon, New Hampshire, United States
Edison, New Jersey, United States
Voorhees Township, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Brussels, , Belgium
Leuven, , Belgium
Campinas, , Brazil
Curitiba, , Brazil
Porto Alegre, , Brazil
Ribeirão Preto, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Vancouver, British Columbia, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Brno, , Czechia
Prague, , Czechia
Lille, , France
Paris, , France
Strasbourg, , France
Kehl, Kork, Germany
Berlin, , Germany
Erlangen, , Germany
Heidelberg, , Germany
Jena, , Germany
Kiel, , Germany
Budapest, , Hungary
Hyderabad, , India
Lucknow, , India
Mahim Mumbai, , India
Mumbai, , India
Pune Maharashtra, , India
Calambrone, , Italy
Genoa, , Italy
Milan, , Italy
Roma, , Italy
Mexico City, , Mexico
Gdansk, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Târgu Mureş, , Romania
Kalingrad, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Cape Town, , South Africa
Capitol Park, , South Africa
Johannesburg, , South Africa
Bristol, , United Kingdom
Cardiff, , United Kingdom
London, , United Kingdom
Countries
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References
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Pina-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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EudraCT number:2004-000200-40
Identifier Type: -
Identifier Source: secondary_id
N01148
Identifier Type: -
Identifier Source: org_study_id
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