Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution
18. November 2014 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
101
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
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Berlin, Deutschland
- 027
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Bielefeld, Deutschland
- 024
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Heidelberg, Deutschland
- 026
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Kehl Kork, Deutschland
- 021
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Kiel, Deutschland
- 023
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Muenster, Deutschland
- 022
-
-
-
-
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Amiens, Frankreich
- 012
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Bron, Frankreich
- 010
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Paris, Frankreich
- 011
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-
-
-
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Athens, Griechenland
- 072
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Patras, Griechenland
- 071
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-
-
-
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Bologna, Italien
- 037
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Calambrone, Italien
- 031
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Milano, Italien
- 032
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Roma, Italien
- 034
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Verona, Italien
- 035
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-
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Gdansk, Polen
- 065
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Lodz, Polen
- 064
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Szczecin, Polen
- 063
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Warszawa, Polen
- 062
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-
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Barcelona, Spanien
- 043
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Madrid, Spanien
- 044
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Madrid, Spanien
- 045
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Murcia, Spanien
- 046
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-
-
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Birmingham, Vereinigtes Königreich
- 057
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Liverpool, Vereinigtes Königreich
- 052
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London, Vereinigtes Königreich
- 051
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
1 Monat bis 11 Monate (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Patients coming to day clinic for consultation by specialist
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2011
Primärer Abschluss (Tatsächlich)
1. November 2013
Studienabschluss (Tatsächlich)
1. November 2013
Studienanmeldedaten
Zuerst eingereicht
23. September 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. September 2010
Zuerst gepostet (Schätzen)
28. September 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
19. November 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. November 2014
Zuletzt verifiziert
1. November 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- N01357
- 2009-017333-21 (EudraCT-Nummer)
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