このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Pioglitazone in Early Parkinson's Disease

2015年9月15日 更新者：University of Rochester

A Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson's Disease

This is a multi-center, double-blind, placebo controlled clinical trial of two dosages of oral pioglitazone (15 milligram(mg) and 45 milligram (mg)) for safety, tolerability, and futility.

Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but no more than 8 months, will be randomized to one of two dosages of oral pioglitazone (15 mg and 45 mg) or matching placebo.

The study will measure disease progression by the change in total Unified Parkinson's Disease Rating Scale (UPDRS) score between the baseline visit and 44 weeks.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

A Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson's Disease (PD). The patient population has early stage PD (< 5 years from diagnosis), must be treated with 1 mg/day of rasagiline or 10 mg/day of selegiline for at least 8 weeks but not more than 8 months prior to enrollment.

The primary objective of this clinical trial is to assess the futility of pioglitazone on PD disease progression as measured by the change in total UPDRS score between the baseline visit and 44 weeks. The secondary objectives of the study are to collect additional efficacy and safety/tolerability data to be used in planning a subsequent Phase III trial of pioglitazone in early, treated PD. Measures of cognition, mood and blood- and urine-based biomarkers will also be explored. Subjects in this trial are randomly assigned in a 1:1:1 ratio to one of three study arms: 15 mg, 45 mg or placebo.

研究の種類

介入

入学 (実際)

210

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

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35294-0017
        • Univeristy of Alabama at Birmingham
    • Arizona
      • Phoenix、Arizona、アメリカ、85013
        • Barrow Neurological Institute
    • California
      • Fountain Valley、California、アメリカ、92708
        • The Parkinson's & Movement Disorder Institute
      • Los Angeles、California、アメリカ、90083
        • University of Southern California
      • San Fransisco、California、アメリカ、94143-0114
        • University of California San Fransisco
    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • Univeristy of Colorado Denver
    • Florida
      • Gainsville、Florida、アメリカ、32610
        • University of Florida
      • Jacksonville、Florida、アメリカ、32209
        • University of Florida, Jacksonville
      • Miami、Florida、アメリカ、33136
        • University of Miami
      • Tampa、Florida、アメリカ、33606
        • University of South Florida
    • Georgia
      • Atlanta、Georgia、アメリカ、30329
        • Emory University School of Medicine
      • Augusta、Georgia、アメリカ、30912
        • Medical College of Georgia
    • Hawaii
      • Honolulu、Hawaii、アメリカ、96819
        • Pacific Health Research & Education Institute
    • Illinois
      • Chicago、Illinois、アメリカ、60611
        • Northwestern University
      • Chicago、Illinois、アメリカ、60612
        • Rush University Medical Center
    • Kansas
      • Kansas City、Kansas、アメリカ、66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington、Kentucky、アメリカ、40536
        • University of Kentucky
    • Louisiana
      • New Orleans、Louisiana、アメリカ、70121
        • Ochsner Clinic Foundation
      • Shreveport、Louisiana、アメリカ、71103
        • LSU Health Science Center Shreveport
    • Maryland
      • Baltimore、Maryland、アメリカ、21287-0875
        • Johns Hopkins University
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
        • Beth Israel Deaconess Medical Center
      • Boston、Massachusetts、アメリカ、02115
        • Brigham & Women's Hospital
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48109-5316
        • University of Michigan
      • East Lansing、Michigan、アメリカ、48824
        • Michigan State University
    • Minnesota
      • Golden Valley、Minnesota、アメリカ、55427
        • Struthers Parkinson's Center
    • Missouri
      • St Louis、Missouri、アメリカ、63110
        • Washington University
    • New Hampshire
      • Lebanon、New Hampshire、アメリカ、03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • Brooklyn、New York、アメリカ、11203-2098
        • Suny Downstate Medical Center
      • Manhasset、New York、アメリカ、11030
        • North Shore - LIJ Health System
    • North Carolina
      • Durham、North Carolina、アメリカ、27705
        • Duke University
    • Oregon
      • Portland、Oregon、アメリカ、97239-3098
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19107
        • Thomas Jefferson University
      • Philadelphia、Pennsylvania、アメリカ、19107
        • University of Pennsylvania
    • South Carolina
      • Charleston、South Carolina、アメリカ、29401
        • Medical University of South Carolina
    • Tennessee
      • Nashville、Tennessee、アメリカ、37232
        • Vanderbilt University
    • Texas
      • Dallas、Texas、アメリカ、75390-9036
        • University of Texas Southwestern Medical Center
    • Vermont
      • Burlington、Vermont、アメリカ、05405
        • University of Vermont
    • Virginia
      • Charlottesville、Virginia、アメリカ、22903
        • University of Virginia

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:

  1. Willing and able to give informed consent.
  2. Men and women with idiopathic PD of less than 5 years duration from diagnosis with a Hoehn and Yahr Stage < 2.
  3. On stable dosage of rasagiline 1 mg/day or selegiline 10 mg/day for at least 8 weeks but not more than 8 months prior to baseline. Expected to remain on stable dose of rasagiline or selegiline as the only treatment for their PD for the duration of the study (44 weeks).
  4. Diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity) being present, without any other known or suspected cause of parkinsonism. The clinical signs must be asymmetric.
  5. Subjects may be taking stable doses (30 days) of anticholinergics or creatine (< 5gm/day) but must be expected to remain on the same dose.
  6. Age > 30 years.
  7. Women who are not postmenopausal or surgically sterile must use a medically accepted contraceptive regimen for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug.

Exclusion Criteria:

  1. Exposure to dopaminergic PD therapy or amantadine within 60 days prior to baseline visit or for 90 days or more at any point in the past
  2. Use of any of the following drugs within 180 days prior to baseline: neuroleptics, metoclopramide, alpha-methyldopa, clozapine, olanzapine and flunarizine.
  3. Use of any of the following drugs within 90 days prior to baseline: methylphenidate, cinnarizine, reserpine, tetrabenazine, amphetamine or monoamine oxidase (MAO)-A inhibitors (pargyline, phenelzine, and tranylcypromine).
  4. Presence of drug-induced parkinsonism (e.g., metoclopramide, flunarizine), metabolic identified neurogenetic disorders (e.g., Wilson's disease), encephalitis, or other atypical Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy).
  5. Participation in other drug studies or receipt of other investigational drugs within 30 days prior to baseline or during the study.
  6. Presence of freezing.
  7. Any clinically significant psychiatric or medical condition or laboratory abnormality, which would in the judgment of the Investigator interfere with the subject's ability to participate.
  8. History of stereotaxic brain surgery for PD
  9. Clinically significant structural brain disease that the investigator believes would interfere with study evaluations.
  10. History of congestive heart failure.
  11. Use of pioglitazone or rosiglitazone within 90 days before randomization.
  12. Known intolerance to pioglitazone or rosiglitazone.
  13. Allergy to rasagiline or selegiline, or contraindication to rasagiline or selegiline use.
  14. Type I or Type II diabetes mellitus.
  15. HgbA1C greater than or equal to 6% at Screening.
  16. Known liver disease or elevation of AST or ALT greater than 2.5 times the upper limit of normal.
  17. Known history of osteoporosis. All women ≥ 65 years of age or men and woman at high risk of osteoporosis should have documented evidence of screening for osteoporosis. Factors associated with high risk of osteoporosis include: previous non traumatic fracture, chronic glucocorticoid use, body weight under 58 kg, family history of hip fracture, current cigarette smoking, and excessive alcohol intake.
  18. Drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with the safe conduct of the study.
  19. Significant peripheral edema (2+ or more) of the extremities of any etiology.
  20. Current or planned use of gemfibrozil or rifampin during the trial.
  21. History of bladder cancer.
  22. Evidence of hematuria which has not been evaluated for evidence of bladder cancer. (Documentation of work up or a repeat urine test that was negative for hematuria and the primary care physician or urologist does not feel that further work up is required.)
  23. History of macular edema.

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：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：15 mg pioglitazone
薬：Pioglitazone

Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd

Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated.

他の名前：
  • ピオグリタゾン塩酸塩
  • ACTOS (R)
実験的：45 mg pioglitazone
薬：Pioglitazone

Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd

Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated.

他の名前：
  • ピオグリタゾン塩酸塩
  • ACTOS (R)
プラセボコンパレーター：Matching Placebo
Placebo
薬：placebo
Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule.

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
メジャーの説明
時間枠
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to 44 Weeks
時間枠：44 weeks

Change in total UPDRS score from baseline to 44 weeks (in subjects treated with rasagiline 1 mg/day or selegiline 10 mg/day).

The Total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes.

The change is 44 weeks - baseline.
44 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Ambulatory Capacity From Baseline to 44 Weeks
時間枠：44 weeks

This is the sum of the 5 UPDRS questions regarding ambulatory capacity: falling, freezing, walking, gait, postural stability.

Ambulatory Capacity is calculated as the sum of items 13-15, 29, 30 of the Unified Parkinson's Disease Rating Scale (UPDRS). It ranges from 0-20. Higher scores are worse. Change is 44 weeks - baseline.
44 weeks
Change in Schwab and England Scale From Baseline to 44 Weeks
時間枠：44 weeks
The modified Schwab and England Activities of Daily Living is a single question ranging from 0-100% with anchors for each 10% interval. Higher scores are better (100% completely independent- 0% vegetative).
44 weeks
Change in Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 44 Weeks
時間枠：44 weeks

The Parkinson's Disease Questionnaire (PDQ-39) is a short, 39 item measure of quality of life in subjects with Parkinson's disease. The questionnaire covers 8 aspects of quality of life: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort.

The total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.
44 weeks
Change in the Mattis Dementia Rating Scale (DRS-2)From Baseline to 44 Weeks
時間枠：44 weeks
The Mattis dementia rating scale is a psychometric instrument designed to assess the extent and nature of dementia. Mattis Dementia Rating scale (DRS-2) raw score is the sum of 5 raw sub-scores (attention has possible 37 points, initiation/perseveration has possible 37 points, construction has possible 6 points, conceptualization has possible 39 points, memory has possible 25 points). Total range is 0-144. Higher scores are better.
44 weeks
Change in the 15-item Geriatric Depression Scale (GDS-15)From Baseline to 44 Weeks
時間枠：44 weeks
The Geriatric Depression Scale - 15 is a short 15 yes or no question instrument for assessing depression in the elderly. It has been found to be particularly useful in assessing depression in Parkinson's Disease. A score of 0 to 5 is normal. A score greater than 5 suggests depression.
44 weeks

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

University of Rochester

協力者

National Institute of Neurological Disorders and Stroke (NINDS)
Michael J. Fox Foundation for Parkinson's Research

捜査官

  • スタディディレクター：Tanya Simuni, MD、Northwestern University
  • スタディディレクター：Karl Kieburtz, MD MPH、University of Rochester

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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

2011年3月1日

一次修了 (実際)

2014年5月1日

研究の完了 (実際)

2014年5月1日

試験登録日

最初に提出

2010年12月3日

QC基準を満たした最初の提出物

2011年1月18日

最初の投稿 (見積もり)

2011年1月20日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年10月14日

QC基準を満たした最後の更新が送信されました

2015年9月15日

最終確認日

2013年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FS-ZONE
  • 5U01NS043128-12 (米国 NIH グラント/契約)

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。

購読する