- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00152516
Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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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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Ribeirao Preto, Brazil
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Rio de Janeiro, Brazil
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Sao Paulo, Brazil
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British Columbia
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Vancouver, British Columbia, Canada
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Ontario
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Brno, Czech Republic
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Praha 4, Czech Republic
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Lille Cedex, France
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Paris, France
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Strasbourg Cedex, France
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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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Kork
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Kehl, Kork, Germany
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Budapest, Hungary
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Hyderabad, India
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Lucknow, India
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Mahim Mumbai, India
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Mumbai, India
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Pune Maharashtra, India
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Calambrone, Italy
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Genoa, Italy
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Milano, 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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Tirgu-Mures, Romania
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Kalingrad, Russian Federation
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Moscow, Russian Federation
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St Petersburg, Russian Federation
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St. Petersburg, Russian Federation
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Cape Town, South Africa
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Capitol Park, South Africa
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Johannesburg, South Africa
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Bristol, United Kingdom
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Cardiff, United Kingdom
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London, United Kingdom
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Alabama
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Mobile, Alabama, United States
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Arizona
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Phoenix, Arizona, United States
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California
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Los Angeles, California, United States
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Colorado
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Denver, Colorado, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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Bradenton, Florida, United States
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Loxahatchee, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Illinois
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Chicago, Illinois, United States
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Louisiana
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New Orleans, Louisiana, United States
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Massachusetts
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Boston, Massachusetts, United States
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Minnesota
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St. Paul, Minnesota, United States
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New Hampshire
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Lebanon, New Hampshire, United States
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New Jersey
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Edison, New Jersey, United States
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Voorhees, New Jersey, United States
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New York
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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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North Carolina
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Chapel Hill, North Carolina, United States
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Ohio
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Cleveland, Ohio, United States
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Pennsylvania
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Tennessee
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Fort Worth, Texas, United States
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Galveston, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Virginia
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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West Virginia
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Morgantown, West Virginia, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit
Exclusion Criteria:
- Patients on a ketogenic diet
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Levetiracetam
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
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Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
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Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
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Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
Time Frame: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
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Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
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Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
Time Frame: Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)
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The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week. Note: Rates were reported as percentages. |
Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)
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Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Time Frame: Subjects with up to 24 weeks of exposure
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For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
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Subjects with up to 24 weeks of exposure
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Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Time Frame: Subjects with greater than 24 weeks of exposure
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For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
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Subjects with greater than 24 weeks of exposure
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Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Time Frame: Subjects with up to 24 weeks of exposure
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For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
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Subjects with up to 24 weeks of exposure
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Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Time Frame: Subjects with greater than 24 weeks of exposure
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For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
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Subjects with greater than 24 weeks of exposure
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Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
Time Frame: greater than or equal to 24 weeks, greater than or equal to 40 weeks
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The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period. The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks. |
greater than or equal to 24 weeks, greater than or equal to 40 weeks
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Percent of Subjects With Each Seizure Type During the Evaluation Period
Time Frame: Evaluation period (48 weeks)
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Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions). Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions). Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions). A subject could experience more than one seizure type. |
Evaluation period (48 weeks)
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Investigator Global Evaluation Scale
Time Frame: End of Evaluation period (week 48 or at point of early discontinuation)
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There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
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End of Evaluation period (week 48 or at point of early discontinuation)
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Parent/Guardian Global Evaluation Scale
Time Frame: End of Evaluation period (week 48 or at point of early discontinuation)
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There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
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End of Evaluation period (week 48 or at point of early discontinuation)
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Subject (>=8 Years Old) Global Evaluation Scale
Time Frame: End of Evaluation period (week 48 or at point of early discontinuation)
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There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
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End of Evaluation period (week 48 or at point of early discontinuation)
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Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)
Time Frame: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
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The Leiter-R AM battery has 10 subtests.
The raw scores of the subtests are converted into scaled scores.
Six composite scores are constructed from the 10 subtest scaled scores.
The Memory Screen is one of them.
It is composed of 2 subtests the Associated Pairs and Forward Memory.
The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15).
Higher scores and positive changes from baseline are better.
The range of the Memory Screen composite score is 44 to 155.
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Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
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Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
Time Frame: Visit 5 (Week 24)
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This score is obtained from a total raw score which is the sum of a battery of individual questions.
It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69).
Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
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Visit 5 (Week 24)
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Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
Time Frame: Visit 7 (week 48)
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This score is obtained from a total raw score which is the sum of a battery of individual questions.
It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69).
Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
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Visit 7 (week 48)
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Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
Time Frame: Visit 5 (week 24)
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This score is obtained from a total raw score which is the sum of a battery of individual questions.
It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69).
Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
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Visit 5 (week 24)
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Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
Time Frame: Visit 7 (week 48)
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This score is obtained from a total raw score which is the sum of a battery of individual questions.
It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69).
Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
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Visit 7 (week 48)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: UCB Clinical Trial Call Center, +1 877 822 9493
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N01148
- EudraCT number:2004-000200-40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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