Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy

14. juli 2011 oppdatert av: Eisai Inc.

A Double-Blind, Randomized, Multicenter, Parallel Group Study to Establish Dose-Response, Safety, and Efficacy of Zonegran (Zonisamide) as Monotherapy in Patients With Newly Diagnosed Epilepsy

The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Epilepsy is characterized by repeated seizures caused by recurrent, abnormal, and excessive synchronous discharges from cerebral neurons. Seizures may be triggered by various causes such as CNS infections, fever, tumors, toxins, vascular disease, degenerative disease, trauma, or may be idiopathic. The type of seizure is usually defined by the initial event, the duration, alterations of consciousness, patterns of motor activity, and post-ictal symptoms. In addition, certain seizure types have characteristic EEG patterns. The International Classification of Epileptic Seizures classifies seizures as partial or generalized. Partial seizures are further classified as simple partial, complex partial (impaired consciousness), or partial seizures secondarily generalized. All partial seizures have onset in a discrete cortical region. Generalized seizures are bilaterally symmetrical and without focal onset and include absence seizures, myoclonic seizures, clonic seizures, tonic seizures, tonic-clonic seizures, and atonic seizures. The goals of treatment include the prevention of seizures, medical management of seizures, and management of the consequences of epilepsy. The study will be conducted with patients who have new onset epilepsy characterized by complex partial seizures and will attempt to characterize the relationship between zonisamide dose and seizure prevention and demonstrate monotherapy efficacy.

Studietype

Intervensjonell

Registrering

165

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Estland
      • Tallinn, Estland, 13419
        • Tallinn Children's Hospital
      • Tartu, Estland, 13419
        • Tartu University Hospital
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • UAB Epilepsy Center
      • Huntsville, Alabama, Forente stater, 35801
        • North Alabama Neuroscience
      • Northport, Alabama, Forente stater, 35476
        • Neurology Clinic, P.C.
    • California
      • Northridge, California, Forente stater, 91325
        • Northridge Neurological Center
      • San Diego, California, Forente stater, 92037
        • Coordinated Clinical Research
    • Florida
      • Maitland, Florida, Forente stater, 32751
        • Neurology Associates
      • Panama City, Florida, Forente stater, 32405
        • Bay Neurological Institute
      • St. Petersburg, Florida, Forente stater, 33701
        • Suncoast Neuroscience Associates, Inc.
      • Tallahassee, Florida, Forente stater, 32308
        • AMO Corporation
      • Tampa, Florida, Forente stater, 33613
        • Florida Epilepsy & Seizure Disorder Center, PA
    • Georgia
      • Decatur, Georgia, Forente stater, 30033
        • Neurology & Headache Specialist of Atlanta, LLC
    • Illinois
      • Springfield, Illinois, Forente stater, 62707
        • Southern Illinois University School of Medicine Dept. of Neurology
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40205
        • Louisville Neuroscience Research Center
    • Maryland
      • Baltimore, Maryland, Forente stater, 21229
        • St. Agnes Health Care, Inc.
    • Missouri
      • Chesterfield, Missouri, Forente stater, 63017
        • The Comprehensive Epilepsy Care Center
    • New York
      • Albany, New York, Forente stater, 12205
        • Upstate Clinical Research Center
      • Orchard Park, New York, Forente stater, 14127
        • Dent Neurological Institute
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Epilepsy Institute of North Carolina
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • River Hills Health Care
    • Pennsylvania
      • Greensburg, Pennsylvania, Forente stater, 15601
        • Westmoreland Neurology Associates, Inc.
    • Rhode Island
      • East Providence, Rhode Island, Forente stater, 02914
        • CNS Research, INC
    • Texas
      • San Antonio, Texas, Forente stater, 78229
        • Neurology Clinic of San Antonio
    • Virginia
      • Roanoke, Virginia, Forente stater, 24014
        • Blue Ridge Research Center
    • Washington
      • Tacoma, Washington, Forente stater, 98405
        • Neurology & Neurosurgery Associates of Tacoma, Inc. P.S.
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin
  • Litauen
      • Kaunas, Litauen, 3007
        • Kaunas Medical University Clinics
      • Vilnius, Litauen, 2600
        • Vilnius University Hospital
  • Ukraina
      • Kharkov, Ukraina, 31002
        • Kharkov State Medical University
      • Kharkov, Ukraina, 31068
        • Institute of Neurology, Psychiatry, and Narcology of AMS Ukraine
      • Kiev, Ukraina, 254655
        • Epilepsy Center
      • Odessa, Ukraina, 9
        • Odessa Medical University
  • Ungarn
      • Budapest, Ungarn, 116
        • Semmelweis University Health Science Faculty
      • Budapest, Ungarn, H1145
        • National Institute of Neurosurgery Epilepsy Center

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

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

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

INCLUSION CRITERIA

  • Patient able and willing to give written informed consent or assent as appropriate in accordance with ICH and GCP guidelines
  • Patient with newly diagnosed epilepsy who has complex partial seizures (with or without secondary generalization)
  • Patient must have at least two well-documented, unprovoked, clinically evaluated and classified complex partial seizures or one well-documented, unprovoked, clinically evaluated and classified complex partial seizure and an abnormal EEG consistent with the diagnosis of epilepsy occurring within one year prior to enrollment
  • Patient must have received less than 2 weeks of prior AED therapy, which will be discontinued at study entry

  • EEG changes consistent with the diagnosis of epilepsy:

    • For patients with two well-documented, unprovoked complex partial seizures within one year prior to enrollment, the EEG results may be normal at the time of testing but, in the opinion of the Investigator, the patient has epilepsy
    • For patients with one well-documented, unprovoked complex partial seizure within one year prior to enrollment, the EEG must be abnormal at the time of testing consistent with the diagnosis of epilepsy
  • Patient age 16 years or greater
  • In the opinion of the Investigator, the patient is in good health
  • Female patients of child-bearing potential must not be pregnant (serum HCG negative) or lactating, and must be using a medically acceptable form of birth control such as abstinence, an adequate barrier method, or hormonal contraceptive; or female patients who are post-menopausal or have had surgical sterilization
  • Patient or caregiver able to follow Investigator instruction, study procedures, maintain diary of concomitant medication use, and report adverse events

EXCLUSION CRITERIA

  • History of status epilepticus
  • Patient with simple partial seizures only
  • A history of non-epileptic seizures (e.g. metabolic or pseudo-seizures)
  • Progressive encephalopathy or findings consistent with progressive CNS disease or lesions (e.g. infection, demyelination, tumor)
  • Clinically significant uncontrolled medical disease in the previous two years (including unstable cardiac, hematological, hepatic, or renal disease)
  • History of acute intermittent porphyria, glucose-6-phosphate dehydrogenase deficiency or hemolytic anemia
  • Renal insufficiency (serum creatinine > 2 mg/dL) or impaired liver function (SGPT/ALT > two times upper limit of normal)
  • History of renal calculi
  • Laboratory test results which, in the opinion of the Investigator, are clinically significant abnormalities
  • History of alcohol or drug abuse
  • Psychiatric illness or mood disorders requiring treatment in previous 6 months; history of suicide attempt or psychosis
  • Use of benzodiazepines (intermittent use as a hypnotic or an PRN AED is allowed)
  • Use of other investigational compounds, experimental drugs or devices within 30 days of the screening visit
  • History of hypersensitivity or allergic reaction to sulfonamides
  • Medical disorder, surgery or medication that might interfere with absorption, distribution, metabolism, or excretion of the study drug

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Dobbelt

Samarbeidspartnere og etterforskere

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

Sponsor

Eisai Inc.

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. februar 2002

Primær fullføring (Faktiske)

1. oktober 2004

Studiet fullført (Faktiske)

1. oktober 2004

Datoer for studieregistrering

Først innsendt

18. mars 2003

Først innsendt som oppfylte QC-kriteriene

18. mars 2003

Først lagt ut (Anslag)

19. mars 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. juli 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juli 2011

Sist bekreftet

1. juli 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AN46046-304

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. .

Abonnere