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Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy

14 luglio 2011 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione

165

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

16 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Doppio

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eisai Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2002

Completamento primario (Effettivo)

1 ottobre 2004

Completamento dello studio (Effettivo)

1 ottobre 2004

Date di iscrizione allo studio

Primo inviato

18 marzo 2003

Primo inviato che soddisfa i criteri di controllo qualità

18 marzo 2003

Primo Inserito (Stima)

19 marzo 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 luglio 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2011

Ultimo verificato

1 luglio 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AN46046-304

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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