Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease
2009年8月27日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
9
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama At Birmingham (052)
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Arizona
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Scottsdale、Arizona、アメリカ、85259
- Mayo Clinic Arizona (060)
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California
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Sunnyvale、California、アメリカ、94085
- The Parkinson's Institute (012)
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Colorado
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Englewood、Colorado、アメリカ、80113
- Colorado Neurological Institute (052)
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Connecticut
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Danbury、Connecticut、アメリカ、06810
- Associated Neurologists, PC (190)
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Manchester、Connecticut、アメリカ、06040
- Eastern Connecticut Neurology Specialists (215)
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New Haven、Connecticut、アメリカ、06510
- Institute for Neurodegenerative Disorders (034)
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Florida
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Boca Raton、Florida、アメリカ、33486
- Parkinson's Disease & Movement Disorders Center of Boca Raton (196)
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Miami、Florida、アメリカ、33136
- University of Miami (014)
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Tampa、Florida、アメリカ、33606
- University of South Florida (019)
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Illinois
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Springfield、Illinois、アメリカ、62794
- Southern Illinois University (138)
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Kentucky
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Lexington、Kentucky、アメリカ、40536
- University of Kentucky (172)
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Louisville、Kentucky、アメリカ、40205
- University of Louisville (087)
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Louisiana
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New Orleans、Louisiana、アメリカ、70121
- Ochsner Clinic Foundation (207)
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Shreveport、Louisiana、アメリカ、71103
- LSU Health Science Center Shreveport (132)
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Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Boston University (040)
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Missouri
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St Louis、Missouri、アメリカ、63110
- Washington University (027)
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New York
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Albany、New York、アメリカ、12208
- Albany Medical College (037)
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Rochester、New York、アメリカ、14618
- University of Rochester (001)
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North Carolina
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Durham、North Carolina、アメリカ、27705
- Duke University Medical Center (119)
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Ohio
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Cincinnati、Ohio、アメリカ、45219
- University of Cincinnati/Cincinnati Children's Hospital (089)
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- University of Pennsylvania (018)
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Texas
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Houston、Texas、アメリカ、77030
- Baylor College of Medicine (007)
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Washington
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Kirkland、Washington、アメリカ、98034
- Booth Gardner Parkinson's Care Center (220)
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin (104)
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
30年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：4
プラセボ
|
aplindore MR tablets administered BID for about 13 weeks
|
|
実験的：1
aplindore 2 mg MR total daily dose
|
aplindore MR tablets administered BID for about 13 weeks
|
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実験的：2
aplindore 6 mg MR total daily dose
|
aplindore MR tablets administered BID for about 13 weeks
|
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実験的：3
aplindore 12 mg MR total daily dose
|
aplindore MR tablets administered BID for about 13 weeks
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Mean change from baseline to end of treatment in the combined scores of Parts II and III of the UPDRS
時間枠：3 months
|
3 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
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
時間枠：3 months
|
3 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年12月1日
一次修了 (予想される)
2009年8月1日
研究の完了 (予想される)
2009年10月1日
試験登録日
最初に提出
2008年12月15日
QC基準を満たした最初の提出物
2008年12月15日
最初の投稿 (見積もり)
2008年12月17日
学習記録の更新
投稿された最後の更新 (見積もり)
2009年8月28日
QC基準を満たした最後の更新が送信されました
2009年8月27日
最終確認日
2009年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。