Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution
18 de noviembre de 2014 actualizado por: UCB Pharma
Observational Sentinel Sites Study in Infants Younger Than 12 Months Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution in Usual Clinical Practice
The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice.
Their data will be collected until they reach the age of 13 months.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This non-interventional sentinel sites post-authorization safety study (PASS) aims to collect additional data on use of Keppra® (Levetiracetam) oral solution in clinical practice, and on efficacy and safety of Keppra® (Levetiracetam) in infants younger than12 months.
Epileptic patients between the age of 1 month and 11 months inclusive can be invited for participation to the non-interventional sentinel sites PASS, after the physician has decided to initiate therapy with Keppra® (Levetiracetam) oral solution (100 mg/ml bottle) and patient has so far been treated with Keppra® (Levetiracetam) for no longer than 10 days.
The patients will be followed and their data will be collected until they reach the age of 13 months.
Tipo de estudio
De observación
Inscripción (Actual)
101
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
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Berlin, Alemania
- 027
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Bielefeld, Alemania
- 024
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Heidelberg, Alemania
- 026
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Kehl Kork, Alemania
- 021
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Kiel, Alemania
- 023
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Muenster, Alemania
- 022
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Barcelona, España
- 043
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Madrid, España
- 044
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Madrid, España
- 045
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Murcia, España
- 046
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Amiens, Francia
- 012
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Bron, Francia
- 010
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Paris, Francia
- 011
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Athens, Grecia
- 072
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Patras, Grecia
- 071
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Bologna, Italia
- 037
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Calambrone, Italia
- 031
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Milano, Italia
- 032
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Roma, Italia
- 034
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Verona, Italia
- 035
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Gdansk, Polonia
- 065
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Lodz, Polonia
- 064
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Szczecin, Polonia
- 063
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Warszawa, Polonia
- 062
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Birmingham, Reino Unido
- 057
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Liverpool, Reino Unido
- 052
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London, Reino Unido
- 051
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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 11 meses (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients coming to day clinic for consultation by specialist
Descripción
Inclusion Criteria:
- diagnosis of epilepsy
- being treated with Keppra® Oral Solution
- aged between 1 month and 11 months inclusive at study baseline
Exclusion Criteria:
- none
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
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients, 1 - 11 months old, prescribed Keppra® oral solution
Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who are between 1 and 11 months old.
The patients will be followed as per current clinical practices for their condition.
The choice of medical treatment, including the concomitant use of other antiepileptic drugs, is made independently by the physician in the regular course of practice and is not influenced by the study protocol.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
Periodo de tiempo: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).
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From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up
Periodo de tiempo: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
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Number of patients with any serious Treatment-Emergent Adverse Events (TEAEs) during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).
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From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
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Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit
Periodo de tiempo: From Baseline through the last Treatment Visit (maximum 12 months)
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Number of patients with any Treatment-Emergent Adverse Events (TEAEs) leading to temporary or permanent discontinuation of Keppra® (Levetiracetam) during the Treatment Period (maximum 12 months).
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From Baseline through the last Treatment Visit (maximum 12 months)
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Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit
Periodo de tiempo: From Baseline to the last Treatment Visit (maximum 12 months)
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Number of patients with presence of deviation from the normal milestones of psychomotor development during the Treatment Period (maximum 12 months).
The treating physician evaluated at each visit, as part of standard clinical practice, the psychomotor development of the patient.
The evaluation of the patient's psychomotor development was categorized by the motor development, the social development and the language development.
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From Baseline to the last Treatment Visit (maximum 12 months)
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Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit
Periodo de tiempo: From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
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For each visit, body weight was measured and standardization for gender and age was performed based on WHO growth charts to obtain z-scores.
For this outcome measure, the mean of the differences of individual body weight z-scores from Safety Follow-up Visit to Baseline was determined.
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From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
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Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit
Periodo de tiempo: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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For each visit, body length was measured and age standardization was performed based on WHO growth charts to obtain z-scores.
For this outcome measure, the difference of body length z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.
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From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit
Periodo de tiempo: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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For each visit, head circumference was measured and age standardization was performed based on WHO growth charts to obtain z-scores.
For this outcome measure, the difference of head circumference z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.
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From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
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Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit
Periodo de tiempo: From Baseline to the last Treatment Visit (maximum 12 months)
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Number of patients with abnormalities noted during physical examination over the Treatment Period (maximum 12 months). Any abnormal findings during the physical examination during the study were reported as Adverse Events (AEs). The Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit cannot be given because abnormalities at Screening are listed only and worsening after Screening were handled as AEs and tabulated along with the other AEs. |
From Baseline to the last Treatment Visit (maximum 12 months)
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Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit
Periodo de tiempo: From Baseline to the last Treatment Visit (maximum 12 months)
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The Number of Patients With Abnormalities Noted During Neurological Examination cannot be given because abnormality frequencies were only determined for single parameters of the neurological examination and therefore a subject might have been counted several times.
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From Baseline to the last Treatment Visit (maximum 12 months)
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Global Evaluation Scale of the Psychomotor Development (GES)
Periodo de tiempo: From Baseline to the last Treatment Visit (maximum 12 months)
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Global evaluation scale of the psychomotor development (GES): physician's assessment of the change from Baseline in the psychomotor development at the last Treatment Visit (maximum timeframe is 12 months). The GES is a 7-point scale with the following options: 7=Marked improvement 6=Moderate improvement 5=Slight improvement 4=No Change 3=Slight worsening 2=Moderate worsening 1=Marked worsening As a variant of this variable, a 3-class variable was derived as follows
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From Baseline to the last Treatment Visit (maximum 12 months)
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Global Evaluation Scale of Epilepsy Severity (GES)
Periodo de tiempo: From Baseline to the last Treatment Visit (maximum time frame is 12 months)
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Global evaluation scale of epilepsy severity (GES): physician's assessment of the change from Baseline of the epilepsy severity at the last Treatment Visit (maximum 12 months). The GES is a 7-point scale that assesses change in the severity of the patient's illness. The GES is a 7-point scale with the following options: 7=Marked improvement 6=Moderate improvement 5=Slight improvement 4=No Change 3=Slight worsening 2=Moderate worsening 1=Marked worsening As a variant of this variable, a 3-class variable was derived as follows
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From Baseline to the last Treatment Visit (maximum time frame is 12 months)
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Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period
Periodo de tiempo: From Baseline through the last Treatment Visit (maximum 12 months)
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Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).
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From Baseline through the last Treatment Visit (maximum 12 months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
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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 enero de 2011
Finalización primaria (Actual)
1 de noviembre de 2013
Finalización del estudio (Actual)
1 de noviembre de 2013
Fechas de registro del estudio
Enviado por primera vez
23 de septiembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
27 de septiembre de 2010
Publicado por primera vez (Estimar)
28 de septiembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de noviembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
18 de noviembre de 2014
Última verificación
1 de noviembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- N01357
- 2009-017333-21 (Número EudraCT)
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. .