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Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution

18 novembre 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Épilepsie

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

101

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Allemagne
- - Berlin, Allemagne
    - 027
  - Bielefeld, Allemagne
    - 024
  - Heidelberg, Allemagne
    - 026
  - Kehl Kork, Allemagne
    - 021
  - Kiel, Allemagne
    - 023
  - Muenster, Allemagne
    - 022
Espagne
- - Barcelona, Espagne
    - 043
  - Madrid, Espagne
    - 044
  - Madrid, Espagne
    - 045
  - Murcia, Espagne
    - 046
France
- - Amiens, France
    - 012
  - Bron, France
    - 010
  - Paris, France
    - 011
Grèce
- - Athens, Grèce
    - 072
  - Patras, Grèce
    - 071
Italie
- - Bologna, Italie
    - 037
  - Calambrone, Italie
    - 031
  - Milano, Italie
    - 032
  - Roma, Italie
    - 034
  - Verona, Italie
    - 035
Pologne
- - Gdansk, Pologne
    - 065
  - Lodz, Pologne
    - 064
  - Szczecin, Pologne
    - 063
  - Warszawa, Pologne
    - 062
Royaume-Uni
- - Birmingham, Royaume-Uni
    - 057
  - Liverpool, Royaume-Uni
    - 052
  - London, Royaume-Uni
    - 051

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 mois à 11 mois (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients coming to day clinic for consultation by specialist

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Groupe / Cohorte

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit Délai: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)	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).	From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up Délai: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)	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).	From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)
Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit Délai: From Baseline through the last Treatment Visit (maximum 12 months)	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).	From Baseline through the last Treatment Visit (maximum 12 months)
Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit Délai: From Baseline to the last Treatment Visit (maximum 12 months)	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.	From Baseline to the last Treatment Visit (maximum 12 months)
Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit Délai: From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)	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.	From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)
Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit Délai: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)	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.	From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit Délai: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)	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.	From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)
Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit Délai: From Baseline to the last Treatment Visit (maximum 12 months)	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)
Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit Délai: From Baseline to the last Treatment Visit (maximum 12 months)	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.	From Baseline to the last Treatment Visit (maximum 12 months)
Global Evaluation Scale of the Psychomotor Development (GES) Délai: From Baseline to the last Treatment Visit (maximum 12 months)	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 "Marked improvement," "Moderate improvement," and "Slight improvement" were defined as "Improved." "No change" was defined as "Stable." "Slight worsening," "Moderate worsening," and "Marked worsening" were defined as "Worsened."	From Baseline to the last Treatment Visit (maximum 12 months)
Global Evaluation Scale of Epilepsy Severity (GES) Délai: From Baseline to the last Treatment Visit (maximum time frame is 12 months)	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 "Marked improvement," "Moderate improvement," and "Slight improvement" were defined as "Improved." "No change" was defined as "Stable." "Slight worsening," "Moderate worsening," and "Marked worsening" were defined as "Worsened."	From Baseline to the last Treatment Visit (maximum time frame is 12 months)
Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period Délai: From Baseline through the last Treatment Visit (maximum 12 months)	Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).	From Baseline through the last Treatment Visit (maximum 12 months)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

UCB Pharma

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

FDA Safety Alerts and Recalls

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2011

Achèvement primaire (Réel)

1 novembre 2013

Achèvement de l'étude (Réel)

1 novembre 2013

Dates d'inscription aux études

Première soumission

23 septembre 2010

Première soumission répondant aux critères de contrôle qualité

27 septembre 2010

Première publication (Estimation)

28 septembre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

19 novembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 novembre 2014

Dernière vérification

1 novembre 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

N01357
2009-017333-21 (Numéro EudraCT)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .