A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
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
2 other identifiers
interventional
116
15 countries
86
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2004
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedOctober 1, 2020
September 1, 2020
2.3 years
September 9, 2005
September 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for partial onset seizures divided by the total number of subjects. If a subject had \< 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy, the subject was counted as a non-responder.
48-hours in Evaluation Period and 48-hours in Selection Period
Secondary Outcomes (10)
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)
48-hours in Evaluation Period and 48-hours in Selection Period
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
48-hours in Evaluation Period and 48-hours in Selection Period
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
48-hours in Evaluation Period and 48-hours in Selection Period
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
48-hours in Evaluation Period and 48-hours in Selection Period
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
48-hours in Evaluation Period and 48-hours in Selection Period
- +5 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORMatching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
Levetiractem
EXPERIMENTAL10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
Interventions
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 solution, which is indistinguishable from the Levetiracetam oral solution.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (86)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Los Angeles, California, United States
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Gainesville, Florida, United States
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Loxahatchee Groves, Florida, United States
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Miami, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Saint Paul, Minnesota, United States
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Lebanon, New Hampshire, United States
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Cherry Hill, New Jersey, United States
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Edison, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Danville, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Spartanburg, South Carolina, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Salt Lake City, Utah, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Argentina
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Mendoza, Argentina
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Pilar Buenos Aires, Argentina
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Brussels, Belgium
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Leuven, Belgium
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Campinas, Brazil
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Curitiba, Brazil
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Porto Alegre, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Vancouver, British Columbia, Canada
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Winnepeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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London, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Saskatoon, Saskatchewan, Canada
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Brno, Czechia
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Prague, Czechia
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Lille, France
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Paris, France
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Rouen, France
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Strasbourg, France
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Kehl, Kork, Germany
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Berlin, Germany
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Erlangen, Germany
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Heidelberg, Germany
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Jena, Germany
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Kiel, Germany
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Budapest, Hungary
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Calambrone, Italy
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Genoa, Italy
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Milan, Italy
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Roma, Italy
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Mexico City, Mexico
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Gdansk, Poland
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Bucharest, Romania
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Cluj-Napoca, Romania
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Târgu Mureş, Romania
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Kalingrad, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Glasgow, United Kingdom
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London, United Kingdom
Related Publications (2)
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.
PMID: 19243423RESULTPina-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.
PMID: 21095488DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
October 1, 2004
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
October 1, 2020
Record last verified: 2020-09