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Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy

14. juli 2011 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding

165

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Dobbelt

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eisai Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2002

Primær færdiggørelse (Faktiske)

1. oktober 2004

Studieafslutning (Faktiske)

1. oktober 2004

Datoer for studieregistrering

Først indsendt

18. marts 2003

Først indsendt, der opfyldte QC-kriterier

18. marts 2003

Først opslået (Skøn)

19. marts 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2011

Sidst verificeret

1. juli 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AN46046-304

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Epilepsi, kompleks delvis

Kliniske forsøg med Zonisamide

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in El Salvador

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner