A Study of the Novel Drug Dimebon in Patients With Huntington's Disease

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NCT00497159

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Study Location
Huntington Study Group
Rochester, New York, 14620, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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[email protected]

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

- Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;

- Able to take medication (capsules) by mouth.

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


- Clinical evidence of unstable medical illness;


- Females who are pregnant or lactating or who intend to become pregnant during the
study period.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of the Novel Drug Dimebon in Patients With Huntington's Disease
Official Title  ICMJE A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
Brief Summary This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE
  • Other: Placebo
    Placebo TID x 90 days
  • Drug: Dimebon
    Dimebon 20 mg TID x 90 days
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo
    Intervention: Other: Placebo
  • Experimental: 2
    Dimebon
    Intervention: Drug: Dimebon
Publications * Kieburtz K, McDermott MP, Voss TS, Corey-Bloom J, Deuel LM, Dorsey ER, Factor S, Geschwind MD, Hodgeman K, Kayson E, Noonberg S, Pourfar M, Rabinowitz K, Ravina B, Sanchez-Ramos J, Seely L, Walker F, Feigin A; Huntington Disease Study Group DIMOND Investigators. A randomized, placebo-controlled trial of latrepirdine in Huntington disease. Arch Neurol. 2010 Feb;67(2):154-60. doi: 10.1001/archneurol.2009.334. Erratum in: Arch Neurol. 2010 Apr;67(4):492. Dimebon in Subjects With Huntington Disease (DIMOND)Investigators of the Huntington Study Group [corrected to Huntington Disease Study Group DIMOND Investigators].

*   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: May 16, 2015)		91
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2007)		90
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
  • Able to take medication (capsules) by mouth.

Exclusion Criteria:

  • Clinical evidence of unstable medical illness;
  • Females who are pregnant or lactating or who intend to become pregnant during the study period.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 29 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00497159
Other Study ID Numbers  ICMJE DIM05
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 Huntington Study Group
Investigators  ICMJE
Principal Investigator:Karl Kieburtz, MD, MPHHuntington Study Group, University of Rochester
PRS Account Medivation, Inc.
Verification Date May 2015

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