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

18. november 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

101

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 måned til 11 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

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Sponsor

UCB Pharma

Publikasjoner og nyttige lenker

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Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2011

Primær fullføring (Faktiske)

1. november 2013

Studiet fullført (Faktiske)

1. november 2013

Datoer for studieregistrering

Først innsendt

23. september 2010

Først innsendt som oppfylte QC-kriteriene

27. september 2010

Først lagt ut (Anslag)

28. september 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. november 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. november 2014

Sist bekreftet

1. november 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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