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

This study has been completed.
Sponsor:
Collaborator:
Huntington Study Group
Information provided by:
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00497159
First received: July 3, 2007
Last updated: July 24, 2008
Last verified: July 2008

July 3, 2007
July 24, 2008
July 2007
June 2008   (final data collection date for primary outcome measure)
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
Complete list of historical versions of study NCT00497159 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To assess the pharmacokinetics of Dimebon. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • 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.
Not Provided
Not Provided
 
A Study of the Novel Drug Dimebon in Patients With Huntington's Disease
A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Huntington's Disease
  • Other: Placebo
    Placebo TID x 90 days
    Other Name: Placebo
  • Drug: Dimebon
    Dimebon 20 mg TID x 90 days
    Other Name: Dimebon
  • Placebo Comparator: 1
    Placebo
    Intervention: Other: Placebo
  • Experimental: 2
    Dimebon
    Intervention: Drug: Dimebon
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]. PubMed PMID: 20142523.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
29 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00497159
DIM05
Yes
Karl Kieburtz, MD, Clinical Trial Coordination Center, University of Rochester
Medivation, Inc.
Huntington Study Group
Principal Investigator: Karl Kieburtz, MD, MPH Huntington Study Group, University of Rochester
Medivation, Inc.
July 2008

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