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

18. november 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

101

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige
        • 057
      • Liverpool, Det Forenede Kongerige
        • 052
      • London, Det Forenede Kongerige
        • 051
  • Frankrig
      • Amiens, Frankrig
        • 012
      • Bron, Frankrig
        • 010
      • Paris, Frankrig
        • 011
  • Grækenland
      • Athens, Grækenland
        • 072
      • Patras, Grækenland
        • 071
  • Italien
      • Bologna, Italien
        • 037
      • Calambrone, Italien
        • 031
      • Milano, Italien
        • 032
      • Roma, Italien
        • 034
      • Verona, Italien
        • 035
  • Polen
      • Gdansk, Polen
        • 065
      • Lodz, Polen
        • 064
      • Szczecin, Polen
        • 063
      • Warszawa, Polen
        • 062
  • Spanien
      • Barcelona, Spanien
        • 043
      • Madrid, Spanien
        • 044
      • Madrid, Spanien
        • 045
      • Murcia, Spanien
        • 046
  • Tyskland
      • Berlin, Tyskland
        • 027
      • Bielefeld, Tyskland
        • 024
      • Heidelberg, Tyskland
        • 026
      • Kehl Kork, Tyskland
        • 021
      • Kiel, Tyskland
        • 023
      • Muenster, Tyskland
        • 022

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 måned til 11 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients coming to day clinic for consultation by specialist

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UCB Pharma

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Faktiske)

1. november 2013

Studieafslutning (Faktiske)

1. november 2013

Datoer for studieregistrering

Først indsendt

23. september 2010

Først indsendt, der opfyldte QC-kriterier

27. september 2010

Først opslået (Skøn)

28. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Epilepsi

  • Boston Children's Hospital
    Rekruttering
    Registrering og naturhistorie med epilepsi-dyskinesi-syndromer
    Epilepsi | Bevægelsesforstyrrelser | Dyskinesier | Ataksi | Neurologisk lidelse | Chorea | Myoklonus | Dyskinesi | Dystoni lidelse | Epilepsi hos børn | EDS | Bevægelsesforstyrrelser hos børn | Epilepsy-dyskinesi | Epilepsi-dyskinesi synkdom
    Forenede Stater

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