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Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures

8 februari 2013 bijgewerkt door: UCB Pharma

A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.

To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

255

Fase

  • Fase 3

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

  • België
      • Brussels, België
      • Leuven, België
  • Brazilië
      • Campinas, Brazilië
      • Curitiba, Brazilië
      • Porto Alegre, Brazilië
      • Ribeirao Preto, Brazilië
      • Rio de Janeiro, Brazilië
      • Sao Paulo, Brazilië
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Thornhill, Ontario, Canada
      • Toronto, Ontario, Canada
  • Duitsland
      • Berlin, Duitsland
      • Erlangen, Duitsland
      • Heidelberg, Duitsland
      • Jena, Duitsland
      • Kiel, Duitsland
    • Kork
      • Kehl, Kork, Duitsland
  • Frankrijk
      • Lille Cedex, Frankrijk
      • Paris, Frankrijk
      • Strasbourg Cedex, Frankrijk
  • Hongarije
      • Budapest, Hongarije
  • Indië
      • Hyderabad, Indië
      • Lucknow, Indië
      • Mahim Mumbai, Indië
      • Mumbai, Indië
      • Pune Maharashtra, Indië
  • Italië
      • Calambrone, Italië
      • Genoa, Italië
      • Milano, Italië
      • Roma, Italië
  • Mexico
      • Mexico City, Mexico
  • Polen
      • Gdansk, Polen
  • Roemenië
      • Bucharest, Roemenië
      • Cluj-Napoca, Roemenië
      • Tirgu-Mures, Roemenië
  • Russische Federatie
      • Kalingrad, Russische Federatie
      • Moscow, Russische Federatie
      • St Petersburg, Russische Federatie
      • St. Petersburg, Russische Federatie
  • Tsjechische Republiek
      • Brno, Tsjechische Republiek
      • Praha 4, Tsjechische Republiek
  • Verenigd Koninkrijk
      • Bristol, Verenigd Koninkrijk
      • Cardiff, Verenigd Koninkrijk
      • London, Verenigd Koninkrijk
  • Verenigde Staten
    • Alabama
      • Mobile, Alabama, Verenigde Staten
    • Arizona
      • Phoenix, Arizona, Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten
    • Colorado
      • Denver, Colorado, Verenigde Staten
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten
    • Florida
      • Bradenton, Florida, Verenigde Staten
      • Loxahatchee, Florida, Verenigde Staten
      • Orlando, Florida, Verenigde Staten
      • Pensacola, Florida, Verenigde Staten
      • Tallahassee, Florida, Verenigde Staten
      • Tampa, Florida, Verenigde Staten
    • Georgia
      • Atlanta, Georgia, Verenigde Staten
      • Augusta, Georgia, Verenigde Staten
    • Illinois
      • Chicago, Illinois, Verenigde Staten
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten
    • Minnesota
      • St. Paul, Minnesota, Verenigde Staten
    • New Hampshire
      • Lebanon, New Hampshire, Verenigde Staten
    • New Jersey
      • Edison, New Jersey, Verenigde Staten
      • Voorhees, New Jersey, Verenigde Staten
    • New York
      • Buffalo, New York, Verenigde Staten
      • New York, New York, Verenigde Staten
      • Rochester, New York, Verenigde Staten
      • Syracuse, New York, Verenigde Staten
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten
    • Ohio
      • Cleveland, Ohio, Verenigde Staten
    • Pennsylvania
      • Hershey, Pennsylvania, Verenigde Staten
      • Philadelphia, Pennsylvania, Verenigde Staten
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten
    • Tennessee
      • Germantown, Tennessee, Verenigde Staten
      • Nashville, Tennessee, Verenigde Staten
    • Texas
      • Fort Worth, Texas, Verenigde Staten
      • Galveston, Texas, Verenigde Staten
    • Utah
      • Salt Lake City, Utah, Verenigde Staten
    • Virginia
      • Norfolk, Virginia, Verenigde Staten
      • Richmond, Virginia, Verenigde Staten
    • West Virginia
      • Morgantown, West Virginia, Verenigde Staten
    • Wisconsin
      • Milwaukee, Wisconsin, Verenigde Staten
  • Zuid-Afrika
      • Cape Town, Zuid-Afrika
      • Capitol Park, Zuid-Afrika
      • Johannesburg, Zuid-Afrika

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 16 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit

Exclusion Criteria:

  • Patients on a ketogenic diet
  • Seizures too close together to accurately count
  • Pseudoseizures
  • Status epilepticus 1 month prior Visit 1
  • Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.

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

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Levetiracetam
Geneesmiddel: levetiracetam (LEV)
Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
Andere namen:
  • Keppra

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Tijdsspanne: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
Tijdsspanne: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
Tijdsspanne: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
Tijdsspanne: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
Tijdsspanne: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
Tijdsspanne: Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
Tijdsspanne: Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)

The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week.

Note: Rates were reported as percentages.
Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Tijdsspanne: Subjects with up to 24 weeks of exposure
For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Subjects with up to 24 weeks of exposure
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Tijdsspanne: Subjects with greater than 24 weeks of exposure
For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Subjects with greater than 24 weeks of exposure
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Tijdsspanne: Subjects with up to 24 weeks of exposure
For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Subjects with up to 24 weeks of exposure
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
Tijdsspanne: Subjects with greater than 24 weeks of exposure
For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Subjects with greater than 24 weeks of exposure
Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
Tijdsspanne: greater than or equal to 24 weeks, greater than or equal to 40 weeks

The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period.

The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks.
greater than or equal to 24 weeks, greater than or equal to 40 weeks
Percent of Subjects With Each Seizure Type During the Evaluation Period
Tijdsspanne: Evaluation period (48 weeks)

Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions).

Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions).

Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions).

A subject could experience more than one seizure type.
Evaluation period (48 weeks)
Investigator Global Evaluation Scale
Tijdsspanne: End of Evaluation period (week 48 or at point of early discontinuation)
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
End of Evaluation period (week 48 or at point of early discontinuation)
Parent/Guardian Global Evaluation Scale
Tijdsspanne: End of Evaluation period (week 48 or at point of early discontinuation)
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
End of Evaluation period (week 48 or at point of early discontinuation)
Subject (>=8 Years Old) Global Evaluation Scale
Tijdsspanne: End of Evaluation period (week 48 or at point of early discontinuation)
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
End of Evaluation period (week 48 or at point of early discontinuation)
Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)
Tijdsspanne: Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155.
Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
Tijdsspanne: Visit 5 (Week 24)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Visit 5 (Week 24)
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
Tijdsspanne: Visit 7 (week 48)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Visit 7 (week 48)
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
Tijdsspanne: Visit 5 (week 24)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Visit 5 (week 24)
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
Tijdsspanne: Visit 7 (week 48)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Visit 7 (week 48)

Medewerkers en onderzoekers

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

Sponsor

UCB Pharma

Onderzoekers

  • Studie directeur: UCB Clinical Trial Call Center, +1 877 822 9493

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.

Algemene publicaties

Nuttige links

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 oktober 2004

Primaire voltooiing (Werkelijk)

1 juni 2008

Studie voltooiing (Werkelijk)

1 juni 2008

Studieregistratiedata

Eerst ingediend

7 september 2005

Eerst ingediend dat voldeed aan de QC-criteria

7 september 2005

Eerst geplaatst (Schatting)

9 september 2005

Updates van studierecords

Laatste update geplaatst (Schatting)

12 februari 2013

Laatste update ingediend die voldeed aan QC-criteria

8 februari 2013

Laatst geverifieerd

1 april 2010

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • N01148
  • EudraCT number:2004-000200-40

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 .

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