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

18 listopada 2014 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

101

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Francja
      • Amiens, Francja
        • 012
      • Bron, Francja
        • 010
      • Paris, Francja
        • 011
  • Grecja
      • Athens, Grecja
        • 072
      • Patras, Grecja
        • 071
  • Hiszpania
      • Barcelona, Hiszpania
        • 043
      • Madrid, Hiszpania
        • 044
      • Madrid, Hiszpania
        • 045
      • Murcia, Hiszpania
        • 046
  • Niemcy
      • Berlin, Niemcy
        • 027
      • Bielefeld, Niemcy
        • 024
      • Heidelberg, Niemcy
        • 026
      • Kehl Kork, Niemcy
        • 021
      • Kiel, Niemcy
        • 023
      • Muenster, Niemcy
        • 022
  • Polska
      • Gdansk, Polska
        • 065
      • Lodz, Polska
        • 064
      • Szczecin, Polska
        • 063
      • Warszawa, Polska
        • 062
  • Włochy
      • Bologna, Włochy
        • 037
      • Calambrone, Włochy
        • 031
      • Milano, Włochy
        • 032
      • Roma, Włochy
        • 034
      • Verona, Włochy
        • 035
  • Zjednoczone Królestwo
      • Birmingham, Zjednoczone Królestwo
        • 057
      • Liverpool, Zjednoczone Królestwo
        • 052
      • London, Zjednoczone Królestwo
        • 051

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

1 miesiąc do 11 miesięcy (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Patients coming to day clinic for consultation by specialist

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

UCB Pharma

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2011

Zakończenie podstawowe (Rzeczywisty)

1 listopada 2013

Ukończenie studiów (Rzeczywisty)

1 listopada 2013

Daty rejestracji na studia

Pierwszy przesłany

23 września 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 września 2010

Pierwszy wysłany (Oszacować)

28 września 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

19 listopada 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 listopada 2014

Ostatnia weryfikacja

1 listopada 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • N01357
  • 2009-017333-21 (Numer EudraCT)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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