Clinical trial NCT00175890: A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
Official title: A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy, Partial
Keywords: Partial Onset Seizure
levetiracetam
Video Electroencephalogram
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 116
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients from 1 month to less than 4 years of age
* 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:

* A ketogenic diet
* 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

Primary outcomes:
measure: Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
timeFrame: 48-hours in Evaluation Period and 48-hours in Selection Period
Secondary outcomes:
measure: Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
timeFrame: 48-hours in Evaluation Period and 48-hours in Selection Period
measure: Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
timeFrame: 48-hours in Evaluation Period and 48-hours in Selection Period
measure: Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
timeFrame: 48-hours in Evaluation Period and 48-hours in Selection Period
measure: Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
timeFrame: 48-hours in Evaluation Period and 48-hours in Selection Period
measure: Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
timeFrame: 48-hours in Evaluation Period and 48-hours in Selection Period
measure: Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old
timeFrame: 48-hours in Evaluation Period and 48-hours in Selection Period
measure: Percentage of drop-outs for any reasons during the study
timeFrame: During the study (up to 20 days)
measure: Percentage of drop-outs due to lack of efficacy during the study
timeFrame: During the study (up to 20 days)
measure: Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy
timeFrame: During the study (up to 20 days)
measure: Time to Exit (TTE) during the Evaluation Period
timeFrame: During Evaluation Period (Day 1 to Day 6)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
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state: Alabama
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city: Little Rock
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state: Arkansas
city: Los Angeles
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state: California
city: Gainesville
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state: Florida
city: Loxahatchee Groves
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state: Florida
city: Miami
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state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
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state: Florida
city: Augusta
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state: Georgia
city: Boise
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state: Idaho
city: Chicago
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state: Illinois
city: New Orleans
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state: Louisiana
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city: Detroit
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state: Michigan
city: Saint Paul
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state: Minnesota
city: Lebanon
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state: New Hampshire
city: Cherry Hill
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state: New Jersey
city: Edison
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state: New Jersey
city: Buffalo
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state: New York
city: New York
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state: New York
city: Rochester
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state: New York
city: Syracuse
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state: New York
city: Chapel Hill
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state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Cincinnati
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state: Ohio
city: Cleveland
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city: Columbus
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state: Ohio
city: Portland
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state: Oregon
city: Danville
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state: Pennsylvania
city: Hershey
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Spartanburg
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state: South Carolina
city: Nashville
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state: Tennessee
city: Dallas
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state: Texas
city: Fort Worth
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state: Texas
city: Salt Lake City
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state: Utah
city: Richmond
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state: Virginia
city: Seattle
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state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Mendoza
country: Argentina
city: Pilar Buenos Aires
country: Argentina
city: Brussels
country: Belgium
city: Leuven
country: Belgium
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
city: Porto Alegre
country: Brazil
city: Ribeirao Preto
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Vancouver
country: Canada
state: British Columbia
city: Winnepeg
country: Canada
state: Manitoba
city: St John's
country: Canada
state: Newfoundland and Labrador
city: London
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
city: Brno
country: Czechia
city: Praha 4
country: Czechia
city: Praha 5
country: Czechia
city: Lille Cedex
country: France
city: Paris
country: France
city: Rouen Cedex
country: France
city: Strasbourg Cedex
country: France
city: Kehl
country: Germany
state: Kork
city: Berlin
country: Germany
city: Erlangen
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Kiel
country: Germany
city: Budapest
country: Hungary
city: Calambrone
country: Italy
city: Genoa
country: Italy
city: Milano
country: Italy
city: Roma
country: Italy
city: Mexico City
country: Mexico
city: Gdansk
country: Poland
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Tirgu-Mures
country: Romania
city: Kalingrad
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.