Study Evaluating CCI-779 in Relapsing Multiple Sclerosis

Back to Search
Print
Bookmark Trial

NCT00228397

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
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.
Relapsing-Remitting Multiple Sclerosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with relapsing-remitting MS or secondary progressive MS with relapses.

- Successful completion of study 3066A2-205-WW with no major protocol violations.

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


- Pregnancy or lactation.


- Clinically important abnormalities on the physical examination, vital signs, or
electrocardiogram (ECG) performed at the last visit of study 3066A2-205-WW (day 252).


- Any adverse events or findings observed in study 3066A2-205-WW that in the opinion of
the investigators would preclude the subject's entry into the extension study.


Please refer to section 16.2 'Discontinuation and Withdrawal of Subjects' regarding
withdrawal of patients who have any clinical abnormalities in hematology or laboratory test
results obtained at the last visit of the double-blind active phase of study 3066A2-205-WW.

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

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.

Advanced Search

Based on your search, you may also be interested in

Relapsing-remitting Multiple SclerosisRebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis
NCT00078338
  1. Birmingham, Alabama
  2. Phoenix, Arizona
  3. Tucson, Arizona
  4. Sacramento, California
  5. San Diego, California
  6. Fort Collins, Colorado
  7. Derby, Connecticut
  8. Fairfield, Connecticut
  9. Miami, Florida
  10. Tampa, Florida
  11. Atlanta, Georgia
  12. Chicago, Illinois
  13. Northbrook, Illinois
  14. Fort Wayne, Indiana
  15. Baltimore, Maryland
  16. Ann Arbor, Michigan
  17. Detroit, Michigan
  18. Detroit, Michigan
  19. Golden Valley, Minnesota
  20. Minneapolis, Minnesota
  21. Henderson, Nevada
  22. Albany, New York
  23. Rochester, New York
  24. Stony Brook, New York
  25. Syracuse, New York
  26. Charlotte, North Carolina
  27. Winston-Salem, North Carolina
  28. Columbus, Ohio
  29. Uniontown, Ohio
  30. Medford, Oregon
  31. Philadelphia, Pennsylvania
  32. Philadelphia, Pennsylvania
  33. Knoxville, Tennessee
  34. Houston, Texas
  35. Round Rock, Texas
  36. Burlington, Vermont
  37. Fairfax, Virginia
  38. Roanoke, Virginia
  39. Seattle, Washington
  40. Charleston, West Virginia
  41. Milwaukee, Wisconsin
  42. Buenos Aires,
  43. Buenos Aires,
  44. Buenos Aires,
  45. Buenos Aires,
  46. Rosario,
  47. Rosario,
  48. Linz,
  49. Riberao Preto-SP,
  50. Marseille,
  51. Rennes cedex,
  52. Mainz,
  53. Munster,
  54. Bari,
  55. Genoa,
  56. Milan,
  57. Rome,
  58. Amsterdam,
  59. Nijmegen,
  60. Moscow,
  61. Moscow,
  62. Moscow,
  63. Moscow,
  64. Nizhniy Novgorod,
  65. Novosibirsk,
  66. Saint-Petersburg,
  67. St Petersburg,
  68. St Petersburg,
  69. St Petersburg,
  70. Yaroslavl,
  71. Barcelona,
  72. Hospitalet de Llobregat,
  73. Malaga,
  74. Sevilla,
  75. Zurich,
  76. Whitechapel, London
  77. London,
  78. Newcastle upon Tyne,
  79. Nottingham,
  80. Nottingham,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Relapsing-Remitting Multiple SclerosisEvaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
NCT00219908
  1. Caen,
  2. Clermont-Ferrand,
  3. Creteil,
  4. Dijon,
  5. Limoges,
  6. Lomme,
  7. Lyon,
  8. Marseille,
  9. Montpellier,
  10. Nancy,
  11. Nice,
  12. Paris,
  13. Paris,
  14. Paris,
  15. Paris,
  16. Strasbourg,
  17. Toulouse,
  18. Bari,
  19. Firenze,
  20. Gallarate,
  21. Genova,
  22. Milano,
  23. Torino,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Relapsing-Remitting Multiple SclerosisStudy Evaluating CCI-779 in Relapsing Multiple Sclerosis
NCT00228397
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating CCI-779 in Relapsing Multiple Sclerosis
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Long-term Extension Study to Determine the Safety, Tolerability, and Preliminary Efficacy of CCI-779 in Subjects With Relapsing Multiple Sclerosis.
Brief Summary To evaluate the safety and tolerability of long-term therapy with 3 dose levels of oral CCI-779 administered to subjects with relapsing MS who completed study 3066A2-205-WW.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE Drug: CCI-779
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
Actual Enrollment  ICMJE
 (submitted: February 11, 2013)		221
Original Enrollment  ICMJE
 (submitted: September 16, 2005)		200
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with relapsing-remitting MS or secondary progressive MS with relapses.
  • Successful completion of study 3066A2-205-WW with no major protocol violations.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Clinically important abnormalities on the physical examination, vital signs, or electrocardiogram (ECG) performed at the last visit of study 3066A2-205-WW (day 252).
  • Any adverse events or findings observed in study 3066A2-205-WW that in the opinion of the investigators would preclude the subject's entry into the extension study.

Please refer to section 16.2 'Discontinuation and Withdrawal of Subjects' regarding withdrawal of patients who have any clinical abnormalities in hematology or laboratory test results obtained at the last visit of the double-blind active phase of study 3066A2-205-WW.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00228397
Other Study ID Numbers  ICMJE 3066A2-210
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 Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

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