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A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures

26. april 2010 oppdatert av: Janssen Cilag Pharmaceutica S.A.C.I., Greece

An Open-label Observation Study of Topiramate Administration as Adjuvant Therapy for Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures and Generalized Tonoclonic Seizures in Adults and Children Aged 2 Years and Older

The purpose of this observational study is to evaluate the safety of topiramate when used in combination with other medications for seizures in adults and children.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Topiramate is a medication that is approved for the treatment of seizures. In accordance with International guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is an open-label, multi-center observational safety study to collect safety information for oral topiramate given in addition to other medications for 3 types of seizures in adults and in children aged 2 years and older.The 3 seizures types are focal epilepsy, LENNOX-GASTAUT syndrome epileptic seizures and generalized tonic-clonic seizures. Patients whose previous treatment for seizures (one or more antiepileptic drugs) has been judged by their physician to be non-satisfactory will receive 6 months of treatment with topiramate in addition to other antiepileptic medication as prescribed by their physician. Topiramate will be given at low doses initially and gradually increased as necessary to control seizure activity in accordance with Summary of Product Characteristics (SmPC). Patients will be asked to keep a diary of adverse events and seizure activity. Safety evaluations (incidence of adverse events, physical examinations, vital signs and laboratory tests) will be performed throughout the study per investigators usual standard of care. At the end of the study, the treating physician may continue treatment with topiramate and other medication as appropriate. The study hypothesis is that topiramate given in combination with other antiepileptic medications will be effective in achieving and maintaining control of seizure activity and is well-tolerated. 225 adult patients and children aged 2 years or older will be enrolled in the study. Study participants should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or generalized tonoclonic seizures, who have undergone treatment with one or more antiepileptic drugs and whose treatment should be judged by the investigator as non-satisfactory. Observational study - No investigational drug administered.

Studietype

Observasjonsmessig

Registrering (Faktiske)

153

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

2 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

225 adult patients and children aged 2 years or older will be enrolled in the study. Study participants should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or generalized tonoclonic seizures, who should have undergone treatment with one or more antiepileptic drugs and whose treatment should be judged by the inverstigator as non-satisfactory.

Beskrivelse

Inclusion Criteria:

  • Non-premenopausal female patients using a medically acceptable contraceptive method as discussed with their doctor
  • History of the type of seizure during the period prior to inclusion in the study and sufficient medical records to document this. Prior treatment until inclusion in the study with one or more antiepileptic drug treatment judged non-satisfactory by the investigator

Exclusion Criteria:

  • Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor
  • Patients with a history of generalized status epilepticus (prolonged seizures) within the last three months
  • Patients with progressive brain tumor or other progressive or degenerative disorders
  • Patients with a history (within the previous six months) of mental or emotional disorders requiring shock treatment or major sedation, monoamine oxidase (MAO) inhibitors or medications which affect the central nervous system
  • Patients with any medical or social condition that may affect their ability to take part in study or the safety of the study
  • Patients who cannot take the drug or fill in the diary, either alone or with help. If help is needed, it should be permanently available throughout the study

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
001
Legemiddel: Topiramate
Individualization of the treatment should begin from 25 mg for 1 week.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Evaluation of the safety of oral topiramate as adjuvant therapy for focal epilepsy, Lennox-Gastaut syndrome epileptic seizures and the generalized tonoclonic seizures in adults and children aged 2 years and older.
Tidsramme: At visit 3-8
At visit 3-8

Sekundære resultatmål

Resultatmål
Tidsramme
Safety & tolerability evaluation will be performed by reporting AEs & Clinical labs.
Tidsramme: Visits:3-8
Visits:3-8
Evaluation of efficacy will be performed with the aid of descriptive statistics.
Tidsramme: Visits:3-8
Visits:3-8
Overall assessments of the improvement in the seriousness of seizures will be performed.
Tidsramme: Visits:3-8
Visits:3-8

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Cilag Pharmaceutica S.A.C.I., Greece

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. november 2003

Studiet fullført (Faktiske)

1. juni 2005

Datoer for studieregistrering

Først innsendt

24. februar 2006

Først innsendt som oppfylte QC-kriteriene

24. februar 2006

Først lagt ut (Anslag)

28. februar 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

27. april 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. april 2010

Sist bekreftet

1. april 2010

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR003472

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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