Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy
2011년 7월 14일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록
165
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kaunas, 리투아니아, 3007
- Kaunas Medical University Clinics
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Vilnius, 리투아니아, 2600
- Vilnius University Hospital
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Alabama
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Birmingham, Alabama, 미국, 35294
- UAB Epilepsy Center
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Huntsville, Alabama, 미국, 35801
- North Alabama Neuroscience
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Northport, Alabama, 미국, 35476
- Neurology Clinic, P.C.
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California
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Northridge, California, 미국, 91325
- Northridge Neurological Center
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San Diego, California, 미국, 92037
- Coordinated Clinical Research
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Florida
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Maitland, Florida, 미국, 32751
- Neurology Associates
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Panama City, Florida, 미국, 32405
- Bay Neurological Institute
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St. Petersburg, Florida, 미국, 33701
- Suncoast Neuroscience Associates, Inc.
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Tallahassee, Florida, 미국, 32308
- AMO Corporation
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Tampa, Florida, 미국, 33613
- Florida Epilepsy & Seizure Disorder Center, PA
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Georgia
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Decatur, Georgia, 미국, 30033
- Neurology & Headache Specialist of Atlanta, LLC
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Illinois
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Springfield, Illinois, 미국, 62707
- Southern Illinois University School of Medicine Dept. of Neurology
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Kentucky
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Louisville, Kentucky, 미국, 40205
- Louisville Neuroscience Research Center
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Maryland
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Baltimore, Maryland, 미국, 21229
- St. Agnes Health Care, Inc.
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Missouri
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Chesterfield, Missouri, 미국, 63017
- The Comprehensive Epilepsy Care Center
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New York
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Albany, New York, 미국, 12205
- Upstate Clinical Research Center
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Orchard Park, New York, 미국, 14127
- Dent Neurological Institute
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North Carolina
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Winston-Salem, North Carolina, 미국, 27103
- Epilepsy Institute of North Carolina
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Ohio
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Cincinnati, Ohio, 미국, 45219
- River Hills Health Care
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Pennsylvania
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Greensburg, Pennsylvania, 미국, 15601
- Westmoreland Neurology Associates, Inc.
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Rhode Island
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East Providence, Rhode Island, 미국, 02914
- CNS Research, INC
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Texas
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San Antonio, Texas, 미국, 78229
- Neurology Clinic of San Antonio
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Virginia
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Roanoke, Virginia, 미국, 24014
- Blue Ridge Research Center
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Washington
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Tacoma, Washington, 미국, 98405
- Neurology & Neurosurgery Associates of Tacoma, Inc. P.S.
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- University of Wisconsin
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Tallinn, 에스토니아, 13419
- Tallinn Children's Hospital
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Tartu, 에스토니아, 13419
- Tartu University Hospital
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Kharkov, 우크라이나, 31002
- Kharkov State Medical University
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Kharkov, 우크라이나, 31068
- Institute of Neurology, Psychiatry, and Narcology of AMS Ukraine
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Kiev, 우크라이나, 254655
- Epilepsy Center
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Odessa, 우크라이나, 9
- Odessa Medical University
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Budapest, 헝가리, 116
- Semmelweis University Health Science Faculty
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Budapest, 헝가리, H1145
- National Institute of Neurosurgery Epilepsy Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
16년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 더블
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2002년 2월 1일
기본 완료 (실제)
2004년 10월 1일
연구 완료 (실제)
2004년 10월 1일
연구 등록 날짜
최초 제출
2003년 3월 18일
QC 기준을 충족하는 최초 제출
2003년 3월 18일
처음 게시됨 (추정)
2003년 3월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 7월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 7월 14일
마지막으로 확인됨
2011년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
간질, 복합 부분에 대한 임상 시험
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Zonisamide에 대한 임상 시험
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Food and Drug Administration (FDA)University of Maryland, Baltimore완전한