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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00387270
Other study ID # DIM03
Secondary ID DIMOND
Status Completed
Phase Phase 1/Phase 2
First received October 10, 2006
Last updated January 3, 2008
Start date October 2006
Est. completion date March 2007

Study information

Verified date September 2007
Source Medivation, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dimebon
Dimebon 10 or 20 mg TID x 7 days

Locations

Country Name City State
United States Huntington Study Group Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
Medivation, Inc. Huntington Study Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicities 7 days Yes
Secondary Unified Huntington's Disease Rating Scale 7 days Yes
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