Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.

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NCT00036218

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Study Location
Pfizer Investigational Site
Hot Springs, Arkansas, 71913, United States
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Contact
1-800-718-1021
[email protected]
Related Links

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
30 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Parkinson's disease of less than 7 years duration

Modified Hoehn and Yahr Scale Stages 1 through 3.

Age greater than or equal to 30 years old.

Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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


Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or
degenerative diseases.


Levodopa received for 1-year accumulated interval in the last two years.


Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days
prior to baseline.


Unstable dose regimes of hypnotics, anxiolytics or antidepressants


Dementia


History of stereotaxic brain surgery, psychosis or active epilepsy within past year.


Participation in clinical trial within the previous 30 days.


Malignant melanoma or history of melanoma


Significant medical or pshychiatric condition.

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]

Call Now

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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+
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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
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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,
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MULTIPLE SITES
Parkinson DiseaseOpen Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease NCT00036205
  1. Birmingham, Alabama
  2. Peoria, Arizona
  3. Tucson, Arizona
  4. Little Rock, Arkansas
  5. Concord, California
  6. Fresno, California
  7. Irvine, California
  8. La Jolla, California
  9. Loma Linda, California
  10. Los Angeles, California
  11. Oceanside, California
  12. San Diego, California
  13. San Francisco, California
  14. San Luis Obiapo, California
  15. Sunnyvale, California
  16. Walnut Creek, California
  17. Denver, Colorado
  18. Englewood, Colorado
  19. Fairfield, Connecticut
  20. Hartford, Connecticut
  21. New Haven, Connecticut
  22. Trumbull, Connecticut
  23. Wilmington, Delaware
  24. Boca Raton, Florida
  25. Clearwater, Florida
  26. Fort Lauderdale, Florida
  27. Jacksonville, Florida
  28. Maitland, Florida
  29. Miami, Florida
  30. Naples, Florida
  31. Orlando, Florida
  32. Palm Beach Gardens, Florida
  33. Plantation, Florida
  34. Sarasota, Florida
  35. St Petersburg, Florida
  36. Tallahassee, Florida
  37. Tampa, Florida
  38. Atlanta, Georgia
  39. Decatur, Georgia
  40. Marietta, Georgia
  41. Savannah, Georgia
  42. Chicago, Illinois
  43. Elkhart, Indiana
  44. Des Moines, Iowa
  45. Dubuque, Iowa
  46. Kansas City, Kansas
  47. Lenexa, Kansas
  48. Crestview Hills, Kentucky
  49. Covington, Louisiana
  50. Lake Charles, Louisiana
  51. Scarborough, Maine
  52. Baltimore, Maryland
  53. Elkridge, Maryland
  54. Frederick, Maryland
  55. Boston, Massachusetts
  56. Bingham Farms, Michigan
  57. Farmington Hills, Michigan
  58. Grand Rapids, Michigan
  59. Royal Oak, Michigan
  60. Traverse City, Michigan
  61. Fridley, Minnesota
  62. Golden Valley, Minnesota
  63. Minneapolis, Minnesota
  64. St. Cloud, Minnesota
  65. Lee's Summit, Missouri
  66. Salisbury, Missouri
  67. Springfield, Missouri
  68. Omaha, Nebraska
  69. Las Vegas, Nevada
  70. Lebanon, New Hampshire
  71. Morristown, New Jersey
  72. New Brunswick, New Jersey
  73. Manhasset, New York
  74. Mineola, New York
  75. Mount Vernon, New York
  76. New York, New York
  77. Rochester, New York
  78. Syracuse, New York
  79. Asheville, North Carolina
  80. Charlotte, North Carolina
  81. Raleigh, North Carolina
  82. Winston-Salem, North Carolina
  83. Canfield, Ohio
  84. Dayton, Ohio
  85. Oklahoma City, Oklahoma
  86. Eugene, Oregon
  87. Norristown, Pennsylvania
  88. Sellersville, Pennsylvania
  89. Upland, Pennsylvania
  90. Knoxville, Tennessee
  91. Memphis, Tennessee
  92. Austin, Texas
  93. Dallas, Texas
  94. Houston, Texas
  95. San Antonio, Texas
  96. Salt Lake City, Utah
  97. Burlington, Vermont
  98. Charlottesville, Virginia
  99. Richmond, Virginia
  100. Bellevue, Washington
  101. Wenatchee, Washington
  102. Marshfield, Wisconsin
  103. Milwaukee, Wisconsin
  104. Buenos Aires, Barcelona
  105. Mar Del Plata, Buenos Aires
  106. Buenos Aires, Capital Federal
  107. Buenos Aires,
  108. Medellin, Antioquia
  109. Bogota, D.c.
  110. Carolina,
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.
Official Title  ICMJE A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.
Brief Summary The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: sumanirole
  • Drug: ropinirole
Study Arms  ICMJE Not Provided
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 Completed
Enrollment  ICMJE
 (submitted: June 6, 2006)		600
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE April 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Parkinson's disease of less than 7 years duration

Modified Hoehn and Yahr Scale Stages 1 through 3.

Age greater than or equal to 30 years old.

Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.

Levodopa received for 1-year accumulated interval in the last two years.

Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.

Unstable dose regimes of hypnotics, anxiolytics or antidepressants

Dementia

History of stereotaxic brain surgery, psychosis or active epilepsy within past year.

Participation in clinical trial within the previous 30 days.

Malignant melanoma or history of melanoma

Significant medical or pshychiatric condition.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years and older   (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 Argentina,   Mexico,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00036218
Other Study ID Numbers  ICMJE 666E-CNS-0075-021
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2006

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