- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Brussels, Belgien
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Leuven, Belgien
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Campinas, Brasilien
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Curitiba, Brasilien
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Porto Alegre, Brasilien
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Ribeirao Preto, Brasilien
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Rio de Janeiro, Brasilien
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Sao Paulo, Brasilien
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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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Kalingrad, Den Russiske Føderation
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Moscow, Den Russiske Føderation
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St Petersburg, Den Russiske Føderation
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St. Petersburg, Den Russiske Føderation
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Bristol, Det Forenede Kongerige
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Cardiff, Det Forenede Kongerige
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London, Det Forenede Kongerige
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Alabama
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Mobile, Alabama, Forenede Stater
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Arizona
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Phoenix, Arizona, Forenede Stater
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California
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Los Angeles, California, Forenede Stater
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Colorado
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Denver, Colorado, Forenede Stater
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District of Columbia
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Washington, District of Columbia, Forenede Stater
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Florida
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Bradenton, Florida, Forenede Stater
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Loxahatchee, Florida, Forenede Stater
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Orlando, Florida, Forenede Stater
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Pensacola, Florida, Forenede Stater
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Tallahassee, Florida, Forenede Stater
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Tampa, Florida, Forenede Stater
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Georgia
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Atlanta, Georgia, Forenede Stater
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Augusta, Georgia, Forenede Stater
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Illinois
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Chicago, Illinois, Forenede Stater
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Louisiana
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New Orleans, Louisiana, Forenede Stater
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Massachusetts
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Boston, Massachusetts, Forenede Stater
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Minnesota
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St. Paul, Minnesota, Forenede Stater
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater
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New Jersey
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Edison, New Jersey, Forenede Stater
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Voorhees, New Jersey, Forenede Stater
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New York
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Buffalo, New York, Forenede Stater
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New York, New York, Forenede Stater
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Rochester, New York, Forenede Stater
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Syracuse, New York, Forenede Stater
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater
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Ohio
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Cleveland, Ohio, Forenede Stater
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater
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Philadelphia, Pennsylvania, Forenede Stater
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South Carolina
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Charleston, South Carolina, Forenede Stater
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Tennessee
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Germantown, Tennessee, Forenede Stater
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Nashville, Tennessee, Forenede Stater
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Texas
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Fort Worth, Texas, Forenede Stater
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Galveston, Texas, Forenede Stater
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Utah
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Salt Lake City, Utah, Forenede Stater
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Virginia
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Norfolk, Virginia, Forenede Stater
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Richmond, Virginia, Forenede Stater
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West Virginia
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Morgantown, West Virginia, Forenede Stater
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater
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Lille Cedex, Frankrig
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Paris, Frankrig
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Strasbourg Cedex, Frankrig
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Hyderabad, Indien
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Lucknow, Indien
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Mahim Mumbai, Indien
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Mumbai, Indien
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Pune Maharashtra, Indien
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Calambrone, Italien
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Genoa, Italien
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Milano, Italien
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Roma, Italien
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Mexico City, Mexico
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Gdansk, Polen
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Bucharest, Rumænien
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Cluj-Napoca, Rumænien
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Tirgu-Mures, Rumænien
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Cape Town, Sydafrika
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Capitol Park, Sydafrika
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Johannesburg, Sydafrika
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Brno, Tjekkiet
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Praha 4, Tjekkiet
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Berlin, Tyskland
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Erlangen, Tyskland
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Heidelberg, Tyskland
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Jena, Tyskland
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Kiel, Tyskland
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Kork
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Kehl, Kork, Tyskland
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Budapest, Ungarn
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Visit 5 (week 24)
|
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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: UCB Clinical Trial Call Center, +1 877 822 9493
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- N01148
- EudraCT number:2004-000200-40
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