A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
NCT ID: NCT00175890
Last Updated: 2020-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
116 participants
INTERVENTIONAL
2004-10-31
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
Placebo
Placebo solution, which is indistinguishable from the Levetiracetam oral solution.
Levetiractem
10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
Levetiracetam
Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.
Interventions
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Levetiracetam
Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.
Placebo
Placebo solution, which is indistinguishable from the Levetiracetam oral solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pediatric patients diagnosed with refractory partial onset seizures, on a stable regimen of one to two other anti-epileptic drugs and at least 2 partial onset seizures per week in the two weeks prior to screening
* Patients must have two partial onset seizures (with corresponding clinical event) during the 48-hour video EEG at screening
Exclusion Criteria
* Previous exposure to levetiracetam
* Seizures too close together to count accurately
* Treatable seizure etiology
* Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease
* Diagnosis of a terminal illness
1 Month
4 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
UCB Pharma
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Gainesville, Florida, United States
Loxahatchee Groves, Florida, United States
Miami, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Saint Paul, Minnesota, United States
Lebanon, New Hampshire, United States
Cherry Hill, New Jersey, United States
Edison, 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
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Danville, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Spartanburg, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Buenos Aires, , Argentina
Mendoza, , Argentina
Pilar Buenos Aires, , Argentina
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
Winnepeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
London, Ontario, Canada
Scarborough Village, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Brno, , Czechia
Prague, , Czechia
Lille, , France
Paris, , France
Rouen, , France
Strasbourg, , France
Kehl, Kork, Germany
Berlin, , Germany
Erlangen, , Germany
Heidelberg, , Germany
Jena, , Germany
Kiel, , Germany
Budapest, , Hungary
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
Glasgow, , United Kingdom
London, , United Kingdom
Countries
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References
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Pina-Garza JE, Nordli DR Jr, Rating D, Yang H, Schiemann-Delgado J, Duncan B; Levetiracetam N01009 Study Group. Adjunctive levetiracetam in infants and young children with refractory partial-onset seizures. Epilepsia. 2009 May;50(5):1141-9. doi: 10.1111/j.1528-1167.2008.01981.x. Epub 2009 Feb 21.
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.
Other Identifiers
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2004-000199-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01009
Identifier Type: -
Identifier Source: org_study_id
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