A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease

NCT00920946

Last updated date
Study Location
Scottsdale, Arizona, 85259, United States
Contact
1-800-718-1021

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By email

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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.
Show details

- Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36

- Have cognitive impairment as noted by the following:

1. A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and

2. A subjective assessment of cognitive impairment with decline from pre-HD levels by the Investigator after interviewing the subject and caregiver;

- Are willing and able to give informed consent

- Aged 30 years or older

- Have a caregiver who assists/spends time with the subject at least five days per week for at least three hours per day and has intimate knowledge of the subject's cognitive, functional, and emotional states, and of the subject's personal care.

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


- Had onset of symptoms prior to age 18


- Have any major medical illness or unstable medical condition within 180 days of
screening that may interfere with the subject's ability to comply with study
procedures and abide by study restrictions, or with the ability to interpret safety
data

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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 A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease
Brief Summary The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease.
Detailed Description This study is a multicenter Phase 3, randomized, double-blind, placebo-controlled safety and efficacy study of Dimebon treatment in subjects with Huntington disease (HD). The study will evaluate Dimebon 20 mg three times daily (TID) administered orally (PO) for six months (26 weeks) compared with matching placebo TID for the primary safety and efficacy analyses. Safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, safety laboratory evaluations, and 12-lead electrocardiogram(ECG)assessments.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Huntington Disease
Intervention  ICMJE
  • Drug: Dimebon
    20 mg Dimebon orally TID
  • Other: Placebo
    Orally TID
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: Dimebon
    Intervention: Drug: Dimebon
Publications * HORIZON Investigators of the Huntington Study Group and European Huntington's Disease Network. A randomized, double-blind, placebo-controlled study of latrepirdine in patients with mild to moderate Huntington disease. JAMA Neurol. 2013 Jan;70(1):25-33. doi: 10.1001/2013.jamaneurol.382.

*   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: October 11, 2016)
403
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have clinical features of HD and a CAG polyglutamate repeat expansion ? 36
  • Have cognitive impairment as noted by the following:

    1. A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and
    2. A subjective assessment of cognitive impairment with decline from pre-HD levels by the Investigator after interviewing the subject and caregiver;
  • Are willing and able to give informed consent
  • Aged 30 years or older
  • Have a caregiver who assists/spends time with the subject at least five days per week for at least three hours per day and has intimate knowledge of the subject's cognitive, functional, and emotional states, and of the subject's personal care.

Exclusion Criteria:

  • Had onset of symptoms prior to age 18
  • Have any major medical illness or unstable medical condition within 180 days of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data
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 Australia,   Canada,   Denmark,   Germany,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00920946
Other Study ID Numbers  ICMJE DIM20
Has Data Monitoring Committee Yes
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