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Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy

2011年7月14日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册

165

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：单组作业
  • 屏蔽：双倍的

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eisai Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2002年2月1日

初级完成 (实际的)

2004年10月1日

研究完成 (实际的)

2004年10月1日

研究注册日期

首次提交

2003年3月18日

首先提交符合 QC 标准的

2003年3月18日

首次发布 (估计)

2003年3月19日

研究记录更新

最后更新发布 (估计)

2011年7月18日

上次提交的符合 QC 标准的更新

2011年7月14日

最后验证

2011年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AN46046-304

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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