Back to resultsSafety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease
Primary Purpose
Huntington's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dimebon
Sponsored by
About this trial
This is an interventional treatment trial for Huntington's Disease focused on measuring Huntington's disease, Dimebon, dose-escalation, Phase 1-2a, randomized, controlled, double-blind, Unified Huntington's Disease Rating Scale
Eligibility Criteria
Inclusion Criteria:
- Clinical features of Huntington's disease and a confirmatory family history of HD, or a CAG repeat expansion greater than or equal to 36
- Stage I,II,III HD and a total functional capacity greater than or equal to 5 on the Unified Huntington's Disease Rating Scale
Exclusion Criteria:
- Clinical evidence of unstable medical illness
Sites / Locations
- Huntington Study Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Dimebon
Outcomes
Primary Outcome Measures
Dose-limiting toxicities
Secondary Outcome Measures
Unified Huntington's Disease Rating Scale
Full Information
NCT ID
NCT00387270
First Posted
October 10, 2006
Last Updated
January 3, 2008
Sponsor
Medivation, Inc.
Collaborators
Huntington Study Group
1. Study Identification
Unique Protocol Identification Number
NCT00387270
Brief Title
Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease
Official Title
A Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medivation, Inc.
Collaborators
Huntington Study Group
4. Oversight
5. Study Description
Brief Summary
This study is being conducted to determine the safety and tolerability of Dimebon in people with Huntington's disease after short-term exposure (one week) and after longer exposure (three months). Also, the study will assess whether or not there is an effect of Dimebon on the symptoms of Huntington's disease, including cognitive (thinking abilities), motor (movement), behavior, and overall functioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease
Keywords
Huntington's disease, Dimebon, dose-escalation, Phase 1-2a, randomized, controlled, double-blind, Unified Huntington's Disease Rating Scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Dimebon
Intervention Type
Drug
Intervention Name(s)
Dimebon
Intervention Description
Dimebon 10 or 20 mg TID x 7 days
Primary Outcome Measure Information:
Title
Dose-limiting toxicities
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Unified Huntington's Disease Rating Scale
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical features of Huntington's disease and a confirmatory family history of HD, or a CAG repeat expansion greater than or equal to 36
Stage I,II,III HD and a total functional capacity greater than or equal to 5 on the Unified Huntington's Disease Rating Scale
Exclusion Criteria:
Clinical evidence of unstable medical illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl D Kieburtz, MD
Organizational Affiliation
University of Rochester Medical School, Huntington Study Group
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
Links:
URL
http://www.huntington-study-group.org
Description
The Huntington Study Group (HSG) is a non-profit group of physicians and other health care providers from medical centers in the U.S., Canada, Europe, and Australia, experienced in the care of Huntington patients and dedicated to clinical research of HD
Learn more about this trial
Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease
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