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Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures

8 de febrero de 2013 actualizado por: UCB Pharma

A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.

To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

255

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania
      • Erlangen, Alemania
      • Heidelberg, Alemania
      • Jena, Alemania
      • Kiel, Alemania
    • Kork
      • Kehl, Kork, Alemania
  • Brasil
      • Campinas, Brasil
      • Curitiba, Brasil
      • Porto Alegre, Brasil
      • Ribeirao Preto, Brasil
      • Rio de Janeiro, Brasil
      • Sao Paulo, Brasil
  • Bélgica
      • Brussels, Bélgica
      • Leuven, Bélgica
  • Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá
    • Ontario
      • Thornhill, Ontario, Canadá
      • Toronto, Ontario, Canadá
  • Estados Unidos
    • Alabama
      • Mobile, Alabama, Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos
    • Colorado
      • Denver, Colorado, Estados Unidos
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos
    • Florida
      • Bradenton, Florida, Estados Unidos
      • Loxahatchee, Florida, Estados Unidos
      • Orlando, Florida, Estados Unidos
      • Pensacola, Florida, Estados Unidos
      • Tallahassee, Florida, Estados Unidos
      • Tampa, Florida, Estados Unidos
    • Georgia
      • Atlanta, Georgia, Estados Unidos
      • Augusta, Georgia, Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos
    • Minnesota
      • St. Paul, Minnesota, Estados Unidos
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos
    • New Jersey
      • Edison, New Jersey, Estados Unidos
      • Voorhees, New Jersey, Estados Unidos
    • New York
      • Buffalo, New York, Estados Unidos
      • New York, New York, Estados Unidos
      • Rochester, New York, Estados Unidos
      • Syracuse, New York, Estados Unidos
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos
    • Ohio
      • Cleveland, Ohio, Estados Unidos
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos
      • Philadelphia, Pennsylvania, Estados Unidos
    • South Carolina
      • Charleston, South Carolina, Estados Unidos
    • Tennessee
      • Germantown, Tennessee, Estados Unidos
      • Nashville, Tennessee, Estados Unidos
    • Texas
      • Fort Worth, Texas, Estados Unidos
      • Galveston, Texas, Estados Unidos
    • Utah
      • Salt Lake City, Utah, Estados Unidos
    • Virginia
      • Norfolk, Virginia, Estados Unidos
      • Richmond, Virginia, Estados Unidos
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos
  • Federación Rusa
      • Kalingrad, Federación Rusa
      • Moscow, Federación Rusa
      • St Petersburg, Federación Rusa
      • St. Petersburg, Federación Rusa
  • Francia
      • Lille Cedex, Francia
      • Paris, Francia
      • Strasbourg Cedex, Francia
  • Hungría
      • Budapest, Hungría
  • India
      • Hyderabad, India
      • Lucknow, India
      • Mahim Mumbai, India
      • Mumbai, India
      • Pune Maharashtra, India
  • Italia
      • Calambrone, Italia
      • Genoa, Italia
      • Milano, Italia
      • Roma, Italia
  • México
      • Mexico City, México
  • Polonia
      • Gdansk, Polonia
  • Reino Unido
      • Bristol, Reino Unido
      • Cardiff, Reino Unido
      • London, Reino Unido
  • República Checa
      • Brno, República Checa
      • Praha 4, República Checa
  • Rumania
      • Bucharest, Rumania
      • Cluj-Napoca, Rumania
      • Tirgu-Mures, Rumania
  • Sudáfrica
      • Cape Town, Sudáfrica
      • Capitol Park, Sudáfrica
      • Johannesburg, Sudáfrica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

1 mes a 16 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Levetiracetam
Droga: levetiracetam (LEV)
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.
Otros nombres:
  • Keppra

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Periodo de tiempo: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Periodo de tiempo: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
Periodo de tiempo: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
Periodo de tiempo: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
Periodo de tiempo: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
Periodo de tiempo: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
Periodo de tiempo: 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)

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)
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Periodo de tiempo: Subjects with up to 24 weeks of exposure
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.
Subjects with up to 24 weeks of exposure
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Periodo de tiempo: Subjects with greater than 24 weeks of exposure
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.
Subjects with greater than 24 weeks of exposure
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Periodo de tiempo: Subjects with up to 24 weeks of exposure
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.
Subjects with up to 24 weeks of exposure
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Periodo de tiempo: Subjects with greater than 24 weeks of exposure
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.
Subjects with greater than 24 weeks of exposure
Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
Periodo de tiempo: greater than or equal to 24 weeks, greater than or equal to 40 weeks

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
Percent of Subjects With Each Seizure Type During the Evaluation Period
Periodo de tiempo: Evaluation period (48 weeks)

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)
Investigator Global Evaluation Scale
Periodo de tiempo: End of Evaluation period (week 48 or at point of early discontinuation)
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).
End of Evaluation period (week 48 or at point of early discontinuation)
Parent/Guardian Global Evaluation Scale
Periodo de tiempo: End of Evaluation period (week 48 or at point of early discontinuation)
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).
End of Evaluation period (week 48 or at point of early discontinuation)
Subject (>=8 Years Old) Global Evaluation Scale
Periodo de tiempo: End of Evaluation period (week 48 or at point of early discontinuation)
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).
End of Evaluation period (week 48 or at point of early discontinuation)
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)
Periodo de tiempo: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
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.
Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
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)
Periodo de tiempo: 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.
Visit 5 (Week 24)
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)
Periodo de tiempo: Visit 7 (week 48)
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.
Visit 7 (week 48)
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)
Periodo de tiempo: 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.
Visit 5 (week 24)
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)
Periodo de tiempo: Visit 7 (week 48)
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.
Visit 7 (week 48)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

UCB Pharma

Investigadores

  • Director de estudio: UCB Clinical Trial Call Center, +1 877 822 9493

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2004

Finalización primaria (Actual)

1 de junio de 2008

Finalización del estudio (Actual)

1 de junio de 2008

Fechas de registro del estudio

Enviado por primera vez

7 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

7 de septiembre de 2005

Publicado por primera vez (Estimar)

9 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de febrero de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

8 de febrero de 2013

Última verificación

1 de abril de 2010

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • N01148
  • EudraCT number:2004-000200-40

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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