Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations

NCT02687542

Last updated date
Study Location
Xenoscience, Inc
Phoenix, Arizona, 85004, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Parkinson Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Females of non-childbearing potential and/or male subjects between the ages of 40 and 85 years, inclusive.

- Clinical diagnosis of Parkinson's disease.

- Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Female of childbearing potential


- History or presence of atypical Parkinsonian syndrome.


- History of surgical intervention for Parkinson's disease.


- Severe acute or chronic medical or psychiatric condition or laboratory abnormality.


- Any condition possibly affecting drug absorption.


- Participation in other studies involving investigational drug(s), or treatment with
any investigational drug within 30 days.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
Duration
The time commitment for participation in the study.
Follow up: Estimated 4 weeks
Screening: Estimated 1 weeks
Treatment: Estimated 15 weeks
Site Visits
Follow up: 1 visits
Screening: Up to 2 visits
Treatment: At least 11 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Possible
Trial Procedures
Blood test
Electrocardiogram (ECG)
Physical examination
Questionnaire
Keeping a diary
Urine test
Vital signs and measurements
Other

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Parkinson DiseasePF 06412562 in Subjects With Advanced Stage Parkinson's Disease
NCT03665454
  1. Hershey, Pennsylvania
ALL GENDERS
0+
years
MULTIPLE SITES
Parkinson DiseaseStudy Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.
NCT00036218
  1. Hot Springs, Arkansas
  2. Little Rock, Arkansas
  3. Carmichael, California
  4. Fresno, California
  5. Irvine, California
  6. La Jolla, California
  7. Loma Linda, California
  8. Los Angeles, California
  9. Oceanside, California
  10. San Francisco, California
  11. San Francisco, California
  12. San Luis Obiapo, California
  13. Walnut Creek, California
  14. Walnut Creek, California
  15. Denver, Colorado
  16. Fairfield, Connecticut
  17. New Haven, Connecticut
  18. Wilmington, Delaware
  19. Boca Raton, Florida
  20. Clearwater, Florida
  21. Fort Lauderdale, Florida
  22. Jacksonville, Florida
  23. Jacksonville, Florida
  24. Maitland, Florida
  25. Miami, Florida
  26. Naples, Florida
  27. Orlando, Florida
  28. Palm Beach Gardens, Florida
  29. Plantation, Florida
  30. St. Petersburg, Florida
  31. Tallahassee, Florida
  32. Tampa, Florida
  33. Atlanta, Georgia
  34. Conyers, Georgia
  35. Decatur, Georgia
  36. Savannah, Georgia
  37. Chicago, Illinois
  38. Chicago, Illinois
  39. Glenbrook, Illinois
  40. Kansas City, Kansas
  41. Lake Charles, Louisiana
  42. Shreveport, Louisiana
  43. Baltimore, Maryland
  44. Columbia, Maryland
  45. Frederick, Maryland
  46. Rockville, Maryland
  47. Boston, Massachusetts
  48. Boston, Massachusetts
  49. Ann Arbor, Michigan
  50. East Lansing, Michigan
  51. Grand Rapids, Michigan
  52. Southfield, Michigan
  53. Traverse City, Michigan
  54. Golden Valley, Minnesota
  55. Minneapolis, Minnesota
  56. St. Cloud, Minnesota
  57. Kansas City, Missouri
  58. Springfield, Missouri
  59. Omaha, Nebraska
  60. Omaha, Nebraska
  61. Henderson, Nevada
  62. Lebanon, New Hampshire
  63. Morristown, New Jersey
  64. New Brunswick, New Jersey
  65. Ridgewood, New Jersey
  66. Manhasset, New York
  67. Mineola, New York
  68. Mount Vernon, New York
  69. New York, New York
  70. New York, New York
  71. New York, New York
  72. Syracuse, New York
  73. Asheville, North Carolina
  74. Raleigh, North Carolina
  75. Oklahoma City, Oklahoma
  76. Oklahoma City, Oklahoma
  77. Norristown, Pennsylvania
  78. Sellersville, Pennsylvania
  79. Upland, Pennsylvania
  80. Knoxville, Tennessee
  81. Memphis, Tennessee
  82. Nashville, Tennessee
  83. Austin, Texas
  84. Dallas, Texas
  85. Houston, Texas
  86. San Antonio, Texas
  87. Salt Lake City, Utah
  88. Burlington, Vermont
  89. Richmond, Virginia
  90. Bellevue, Washington
  91. Spokane, Washington
  92. Wenatchee, Washington
  93. Milwaukee, Wisconsin
  94. Mar Del Plata, Buenos Aires
  95. Buenos Aires, Capital Federal
  96. Buenos Aires, Capital Federal
  97. Buenos Aires,
  98. Buenos Aires,
  99. Buenos Aires,
  100. Mexico City, Mexico D.F.
  101. Monterrey, Nuevo Leon
  102. Carolina,
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Parkinson DiseaseEfficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
NCT02847650
  1. Phoenix, Arizona
  2. Phoenix, Arizona
  3. Boca Raton, Florida
  4. Miami, Florida
  5. Tampa, Florida
  6. Tampa, Florida
  7. Tampa, Florida
  8. Tampa, Florida
  9. Atlanta, Georgia
  10. Chicago, Illinois
  11. Kansas City, Kansas
  12. Boston, Massachusetts
  13. Boston, Massachusetts
  14. Asheville, North Carolina
  15. Cleveland, Ohio
  16. Toledo, Ohio
  17. Toledo, Ohio
  18. Greenville, Texas
  19. Houston, Texas
  20. Virginia Beach, Virginia
  21. CRÉTEIL Cedex,
  22. Créteil,
  23. Grenoble,
  24. La Tronche,
  25. Marseille,
  26. Marseille,
  27. Paris,
  28. Paris,
  29. Bochum, Nordrhein-westfalen
  30. Gera,
  31. Haag I. OB,
  32. Kassel,
  33. Marburg,
  34. Tuebingen,
  35. Ulm,
  36. Holon,
  37. Holon,
ALL GENDERS
45 Years+
years
MULTIPLE SITES
Parkinson DiseaseEfficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
NCT02687542
  1. Phoenix, Arizona
  2. Phoenix, Arizona
  3. Arcadia, California
  4. Loma Linda, California
  5. Newport Beach, California
  6. Newport Beach, California
  7. Pasadena, California
  8. Torrance, California
  9. Fairfield, Connecticut
  10. Boca Raton, Florida
  11. Gainesville, Florida
  12. Ormond Beach, Florida
  13. Tampa, Florida
  14. Vero Beach, Florida
  15. Atlanta, Georgia
  16. Chicago, Illinois
  17. Indianapolis, Indiana
  18. Boston, Massachusetts
  19. Marlton, New Jersey
  20. Amherst, New York
  21. Amherst, New York
  22. Orchard Park, New York
  23. Durham, North Carolina
  24. Durham, North Carolina
  25. Raleigh, North Carolina
  26. Cleveland, Ohio
  27. Toledo, Ohio
  28. Tulsa, Oklahoma
  29. Willow Grove, Pennsylvania
  30. Providence, Rhode Island
  31. Greenville, Texas
  32. Houston, Texas
  33. Kirkland, Washington
  34. Montreal, Quebec
  35. Montreal, Quebec
  36. Grenoble,
  37. La Tronche,
  38. Lille,
  39. Marseille,
  40. Marseille,
  41. Paris,
  42. Freiburg, Baden-wuerttemberg
  43. Bochum,
  44. Dresden,
  45. Muenchen,
  46. Ulm,
  47. Asahikawa, Hokkaido
  48. Morioka, Iwate
  49. Kita-ku, Osaka
  50. Suita, Osaka
  51. Bunkyo-ku, Tokyo
  52. Santiago de Compostela, A Coruna
  53. Hospitalet de Llobregat, Barcelona
  54. San Sebastian, Guipuzcoa
  55. Barcelona,
  56. Madrid,
  57. Valencia,
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
Official Title  ICMJE A 15-week, Phase 2, Double Blind, Randomized, Placebo-controlled, Dose Ranging Study To Investigate The Efficacy, Safety And Tolerability Of Pf-06649751 In Subjects With Motor Fluctuations Due To Parkinson's Disease
Brief Summary The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.
Detailed Description The study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 198 subjects will be randomized to 5 treatment groups. Each subject will participate in the study for approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Drug: PF-06649751 low dose (1 mg QD)
    PF-06649751 low dose (1 mg QD)
  • Drug: PF-06649751 middle dose 1 (3 mg QD)
    PF-06649751 lower middle dose 1 (3 mg QD)
  • Drug: PF-06649751 middle dose 2 (7 mg QD)
    PF-06649751higher middle dose 2 (7 mg QD)
  • Drug: PF-06649751 high dose (15 mg QD)
    PF-06649751 high dose (15 mg QD)
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06649751 low dose (1 mg QD)
    PF-06649751 low dose level (1 mg QD)
    Intervention: Drug: PF-06649751 low dose (1 mg QD)
  • Experimental: PF-06649751 middle dose 1 (3 mg QD)
    PF-06649751 lower middle dose 1 (3 mg QD)
    Intervention: Drug: PF-06649751 middle dose 1 (3 mg QD)
  • Experimental: PF-06649751 middle dose 2 (7 mg QD)
    PF-06649751 higher middle dose 2 (7 mg QD)
    Intervention: Drug: PF-06649751 middle dose 2 (7 mg QD)
  • Experimental: PF-06649751 high dose (15 mg QD)
    PF-06649751 high dose (15 mg QD)
    Intervention: Drug: PF-06649751 high dose (15 mg QD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 20, 2017)
108
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2016)
198
Actual Study Completion Date  ICMJE November 10, 2017
Actual Primary Completion Date November 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females of non-childbearing potential and/or male subjects between the ages of 40 and 85 years, inclusive.
  • Clinical diagnosis of Parkinson's disease.
  • Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion Criteria:

  • Female of childbearing potential
  • History or presence of atypical Parkinsonian syndrome.
  • History of surgical intervention for Parkinson's disease.
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
  • Any condition possibly affecting drug absorption.
  • Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Japan,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02687542
Other Study ID Numbers  ICMJE B7601003
2015-004912-39 ( EudraCT Number )
A-ROSE PD ( Other Identifier: Alias Study Number )
A-ROSE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP