Back to resultsA Study of the Novel Drug Dimebon in Patients With Huntington's Disease (DIMOND)
Primary Purpose
Huntington's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Dimebon
Sponsored by
About this trial
This is an interventional treatment trial for Huntington's Disease focused on measuring Trial of Dimebon to treat patients with mild-to-moderate Huntington's disease.
Eligibility Criteria
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.
Sites / Locations
- Huntington Study Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Placebo
Dimebon
Outcomes
Primary Outcome Measures
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00497159
First Posted
July 3, 2007
Last Updated
May 16, 2015
Sponsor
Medivation, Inc.
Collaborators
Huntington Study Group
1. Study Identification
Unique Protocol Identification Number
NCT00497159
Brief Title
A Study of the Novel Drug Dimebon in Patients With Huntington's Disease
Acronym
DIMOND
Official Title
A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivation, Inc.
Collaborators
Huntington Study Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease
Keywords
Trial of Dimebon to treat patients with mild-to-moderate Huntington's disease.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Dimebon
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo TID x 90 days
Intervention Type
Drug
Intervention Name(s)
Dimebon
Intervention Description
Dimebon 20 mg TID x 90 days
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
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
Title
To assess the pharmacokinetics of Dimebon.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Kieburtz, MD, MPH
Organizational Affiliation
Huntington Study Group, University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntington Study Group
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20142523
Citation
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].
Results Reference
derived
Links:
URL
http://www.huntington-study-group.org
Description
The Huntington Study Group is a non-profit group of physicians and health care providers from medical centers in the US, Canada, Europe, and Australia, experienced in the care of HD patients and dedicated to clinical research of HD. Click for more info.
Learn more about this trial
A Study of the Novel Drug Dimebon in Patients With Huntington's Disease
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