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

18 november 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Epilepsie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

101

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Duitsland
- - Berlin, Duitsland
    - 027
  - Bielefeld, Duitsland
    - 024
  - Heidelberg, Duitsland
    - 026
  - Kehl Kork, Duitsland
    - 021
  - Kiel, Duitsland
    - 023
  - Muenster, Duitsland
    - 022
Frankrijk
- - Amiens, Frankrijk
    - 012
  - Bron, Frankrijk
    - 010
  - Paris, Frankrijk
    - 011
Griekenland
- - Athens, Griekenland
    - 072
  - Patras, Griekenland
    - 071
Italië
- - Bologna, Italië
    - 037
  - Calambrone, Italië
    - 031
  - Milano, Italië
    - 032
  - Roma, Italië
    - 034
  - Verona, Italië
    - 035
Polen
- - Gdansk, Polen
    - 065
  - Lodz, Polen
    - 064
  - Szczecin, Polen
    - 063
  - Warszawa, Polen
    - 062
Spanje
- - Barcelona, Spanje
    - 043
  - Madrid, Spanje
    - 044
  - Madrid, Spanje
    - 045
  - Murcia, Spanje
    - 046
Verenigd Koninkrijk
- - Birmingham, Verenigd Koninkrijk
    - 057
  - Liverpool, Verenigd Koninkrijk
    - 052
  - London, Verenigd Koninkrijk
    - 051

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 maand tot 11 maanden (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients coming to day clinic for consultation by specialist

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Groep / Cohort

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

UCB Pharma

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

FDA Safety Alerts and Recalls

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2011

Primaire voltooiing (Werkelijk)

1 november 2013

Studie voltooiing (Werkelijk)

1 november 2013

Studieregistratiedata

Eerst ingediend

23 september 2010

Eerst ingediend dat voldeed aan de QC-criteria

27 september 2010

Eerst geplaatst (Schatting)

28 september 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

19 november 2014

Laatste update ingediend die voldeed aan QC-criteria

18 november 2014

Laatst geverifieerd

1 november 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

N01357
2009-017333-21 (EudraCT-nummer)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .