Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease
2009년 8월 27일 업데이트: Neurogen Corporation
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED)
This is a clinical trial to be conducted at multiple Parkinson Study Group (PSG) sites in the USA.
Patients with early Parkinson disease will be randomly allocated to one of 4 arms in the study.
The 4 arms include 3 arms with different doses of aplindore MR tablets and 1 placebo arm.
The study drug will be taken twice a day (BID).
The study is blinded and neither subjects, nor the investigators, will know what treatment the subject is receiving.
Investigational study drug will be adjusted to the assigned dosage and then maintained at that dosage for the balance of the 12 week follow-up period.
The entire study will take about 13 weeks.
The study will assess the safety and tolerability of aplindore and measure how effective aplindore is in improving movement and other effects of Parkinson disease.
연구 개요
상세 설명
One hundred and sixty eight patients will be randomly assigned to one of four investigational treatment regimens in this outpatient study.
For active treatment arms, study drug will be titrated to the assigned dosage and then maintained for up to a 12 week follow-up period before receiving tapered doses in advance of study completion.
Dosing will take place over a total of about 13 weeks.
연구 유형
중재적
등록 (실제)
9
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama At Birmingham (052)
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Arizona
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic Arizona (060)
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California
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Sunnyvale, California, 미국, 94085
- The Parkinson's Institute (012)
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Colorado
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Englewood, Colorado, 미국, 80113
- Colorado Neurological Institute (052)
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Connecticut
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Danbury, Connecticut, 미국, 06810
- Associated Neurologists, PC (190)
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Manchester, Connecticut, 미국, 06040
- Eastern Connecticut Neurology Specialists (215)
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New Haven, Connecticut, 미국, 06510
- Institute for Neurodegenerative Disorders (034)
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Florida
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Boca Raton, Florida, 미국, 33486
- Parkinson's Disease & Movement Disorders Center of Boca Raton (196)
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Miami, Florida, 미국, 33136
- University of Miami (014)
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Tampa, Florida, 미국, 33606
- University of South Florida (019)
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Illinois
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Springfield, Illinois, 미국, 62794
- Southern Illinois University (138)
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Kentucky
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Lexington, Kentucky, 미국, 40536
- University of Kentucky (172)
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Louisville, Kentucky, 미국, 40205
- University of Louisville (087)
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Louisiana
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New Orleans, Louisiana, 미국, 70121
- Ochsner Clinic Foundation (207)
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Shreveport, Louisiana, 미국, 71103
- LSU Health Science Center Shreveport (132)
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Massachusetts
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Boston, Massachusetts, 미국, 02118
- Boston University (040)
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Missouri
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St Louis, Missouri, 미국, 63110
- Washington University (027)
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New York
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Albany, New York, 미국, 12208
- Albany Medical College (037)
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Rochester, New York, 미국, 14618
- University of Rochester (001)
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North Carolina
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Durham, North Carolina, 미국, 27705
- Duke University Medical Center (119)
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Ohio
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Cincinnati, Ohio, 미국, 45219
- University of Cincinnati/Cincinnati Children's Hospital (089)
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- University of Pennsylvania (018)
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Texas
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Houston, Texas, 미국, 77030
- Baylor College of Medicine (007)
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Washington
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Kirkland, Washington, 미국, 98034
- Booth Gardner Parkinson's Care Center (220)
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin (104)
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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
30년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Male or female at least 30 years old;
- Initial diagnosis of idiopathic PD must be within 5 years;
- At least two of the following cardinal signs must be present: bradykinesia, resting tremor, and rigidity;
- PD progression must be Stage 1 to 2.5 (inclusive) according to the modified Hoehn and Yahr classification system;
- Have a score on the MoCA of at least 26;
- Have a score on the Beck Depression Inventory II (BDI II) of less than 15;
- Have a screening UPDRS (Part III) motor score of at least 10;
- In good general health as determined by a thorough medical history and physical examination (including vital signs), neurological examination, 12-lead ECG, and clinical chemistry laboratory tests;
- Females of childbearing potential must be using an acceptable method of contraception and have a negative serum pregnancy test at the screening and baseline visits. Acceptable methods of contraception are oral, intrauterine, implantable, injectable contraceptives, double barrier methods or condoms impregnated with spermicide. After screening, subjects using oral contraceptive methods of contraception must agree to add an additional method until 30 days after the last dose of study medication. Women on oral contraceptives or using cervical rings must have been using them for at least 1 month before the screening visit;
- Male subjects with partners of childbearing potential must use adequate contraception during the study and for 3 months after the study;
- Females receiving hormone replacement therapy must be on a stable regimen for at least 3 months;
- Able to read, understand, and provide written/dated informed consent before enrolling in the study, and must be willing to comply with all study procedures.
Exclusion Criteria:
- History or clinical features consistent with an atypical parkinsonian syndrome;
- History of surgical intervention for PD;
- History of severe allergic or anaphylactic reaction to any drug;
- History of allergies or known sensitivity, hypersensitivity, or severe adverse reaction (e.g., requiring abrupt discontinuation) to any drug similar to aplindore;
- Taking prescription drug therapy or over the counter medication for chronic medical conditions who have not been on stable doses for at least 1 month before the screening visit;
- Treated with L-dopa within 2 months before the baseline visit or who have had cumulative treatment exceeding 2 months;
- Have taken dopamine agonist therapy within 1 month before the baseline visit or who have taken dopamine agonist therapy for a cumulative period exceeding 2 months;
- Are receiving amantadine, anticholinergics, or monoamine oxidase B inhibitors who have not been taking stable doses for at least 2 months before the baseline visit;
- A clinically significantly abnormal clinical laboratory value as judged by the investigator or a value that is disapproved by the study Clinical Monitor;
- A decrease in either systolic blood pressure of at least 40 mmHg or a decrease in diastolic blood pressure of at least 20 mmHg following 5 minutes supine and 2 minutes standing, at or within 6 months before the baseline visit;
- Clinically significant ECG findings, including prolonged QTcF intervals (>450 msec for men, >470 msec for women);
- Evidence of clinically significant unstable allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease;
- History of basal or squamous cell skin cancers or carcinoma in situ of the cervix within 2 years before the screening visit are excluded; for all other cancer diagnoses, subjects with a history within 5 years before the screening visit are excluded;
- Any condition that may significantly affect drug absorption;
- Pregnant or lactating females;
- History or evidence of drug abuse or alcoholism as defined by DSM-IV TR within 12 months before the baseline visit or evidence of current withdrawal from drugs or alcohol before the baseline visit;
- Prior exposure to aplindore;
- Received any investigational drug within 60 days before the baseline visit.
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: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 4
위약
|
aplindore MR tablets administered BID for about 13 weeks
|
|
실험적: 1
aplindore 2 mg MR total daily dose
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aplindore MR tablets administered BID for about 13 weeks
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실험적: 2
aplindore 6 mg MR total daily dose
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aplindore MR tablets administered BID for about 13 weeks
|
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실험적: 3
aplindore 12 mg MR total daily dose
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aplindore MR tablets administered BID for about 13 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Mean change from baseline to end of treatment in the combined scores of Parts II and III of the UPDRS
기간: 3 months
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3 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
The responder rate; Part II and Part III scores (separately) of the UPDRS; mean change from baseline in the modified Schwab and England Activities of Daily Living; time course in UPDRS and in modified S&E-ADL; safety and tolerability of aplindore MR
기간: 3 months
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3 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
2008년 12월 1일
기본 완료 (예상)
2009년 8월 1일
연구 완료 (예상)
2009년 10월 1일
연구 등록 날짜
최초 제출
2008년 12월 15일
QC 기준을 충족하는 최초 제출
2008년 12월 15일
처음 게시됨 (추정)
2008년 12월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2009년 8월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2009년 8월 27일
마지막으로 확인됨
2009년 8월 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. .