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Trial record 1 of 1 for:    NCT00497159
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A Study of the Novel Drug Dimebon in Patients With Huntington's Disease (DIMOND)

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ClinicalTrials.gov Identifier: NCT00497159
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Huntington Study Group
Information provided by (Responsible Party):
Medivation, Inc.

Tracking Information
First Submitted Date  ICMJE July 3, 2007
First Posted Date  ICMJE July 6, 2007
Last Update Posted Date June 8, 2015
Study Start Date  ICMJE July 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease. [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2007)
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
Change History Complete list of historical versions of study NCT00497159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
  • To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease. [ Time Frame: 90 days ]
  • To assess the pharmacokinetics of Dimebon. [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2007)
  • To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.
  • To assess the pharmacokinetics of Dimebon.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, MPH Huntington 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