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

Huntington's Disease Clinical Trial

— DIMOND  

Official title:

A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497159
• Other study ID #: DIM05
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2007
• Last updated: May 16, 2015
• Start date: July 2007
• Est. completion date: June 2008

Study information

• Verified date: May 2015
• Source: Medivation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 29 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

Other:
• Placebo
Placebo TID x 90 days

Drug:
• Dimebon
Dimebon 20 mg TID x 90 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	To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.		90 days	Yes
Secondary	To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.		90 days	No
Secondary	To assess the pharmacokinetics of Dimebon.		90 days	Yes

External Links

•   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.