An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease

NCT01085266

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Huntington 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.
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- Successful completion of 26 weeks of blinded treatment in the HORIZON study

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Any other medical illness or unstable medical condition that may interfere with their
ability to comply with study procedures and abide by study restrictions, or may
interfere with the ability to interpret safety information.

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Huntington DiseaseA Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
NCT00920946
  1. Scottsdale, Arizona
  2. Davis, California
  3. Irvine, California
  4. La Jolla, California
  5. San Francisco, California
  6. Gainsville, Florida
  7. Miami, Florida
  8. Boise, Idaho
  9. Indianapolis, Indiana
  10. Kansas City, Kansas
  11. Wichita, Kansas
  12. Charlestown, Massachusetts
  13. Golden Valley, Minnesota
  14. St. Louis, Missouri
  15. New York, New York
  16. Rochester, New York
  17. Durham, North Carolina
  18. Winstom-Salem, North Carolina
  19. Cleveland, Ohio
  20. Columbus, Ohio
  21. Portland, Oregon
  22. Philadelphia, Pennsylvania
  23. Pittsburgh, Pennsylvania
  24. Milwaukee, Wisconsin
  25. Wentworthville, New South Wales
  26. Melbourne, Victoria
  27. Perth,
  28. Vancouver, British Columbia
  29. London, Ontario
  30. Montreal, Quebec
  31. Copenhagen,
  32. Oberer Eslebberg, Ulm
  33. Aachen,
  34. Bochum,
  35. Hamburg,
  36. Stockholm,
  37. Birmingham,
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
Official Title  ICMJE HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
Brief Summary An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with Huntington disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Huntington Disease
Intervention  ICMJE Drug: Dimebon (latrepirdine)
Study Arms  ICMJE Experimental: Dimebon (latrepirdine)
Patients receive dimebon 10mg orally 3 times per day for 1 week and 20 mg orally 3 times per day thereafter.
Intervention: Drug: Dimebon (latrepirdine)
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: October 11, 2016)
362
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Successful completion of 26 weeks of blinded treatment in the HORIZON study

Exclusion Criteria:

  • Any other medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01085266
Other Study ID Numbers  ICMJE DIM20EXT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medivation, Inc.
Study Sponsor  ICMJE Medivation, Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Medivation, Inc.
Verification Date October 2016

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