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Pioglitazone in Early Parkinson's Disease

15. September 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

210

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

30 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 15 mg pioglitazone
Arzneimittel: 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.

Andere Namen:
  • Pioglitazonhydrochlorid
  • ACTOS (R)
Experimental: 45 mg pioglitazone
Arzneimittel: 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.

Andere Namen:
  • Pioglitazonhydrochlorid
  • ACTOS (R)
Placebo-Komparator: Matching Placebo
Placebo
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to 44 Weeks
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Ambulatory Capacity From Baseline to 44 Weeks
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Rochester

Mitarbeiter

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

Ermittler

  • Studienleiter: Tanya Simuni, MD, Northwestern University
  • Studienleiter: Karl Kieburtz, MD MPH, University of Rochester

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2011

Primärer Abschluss (Tatsächlich)

1. Mai 2014

Studienabschluss (Tatsächlich)

1. Mai 2014

Studienanmeldedaten

Zuerst eingereicht

3. Dezember 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Januar 2011

Zuerst gepostet (Schätzen)

20. Januar 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

14. Oktober 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. September 2015

Zuletzt verifiziert

1. September 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FS-ZONE
  • 5U01NS043128-12 (US NIH Stipendium/Vertrag)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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