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

NCT ID: NCT00497159

Last Updated: 2015-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Huntington's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo TID x 90 days

2

Dimebon

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Dimebon 20 mg TID x 90 days

Interventions

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Placebo

Placebo TID x 90 days

Intervention Type OTHER

Dimebon

Dimebon 20 mg TID x 90 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huntington Study Group

NETWORK

Sponsor Role collaborator

Medivation, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl Kieburtz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Huntington Study Group, University of Rochester

Locations

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Huntington Study Group

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20142523 (View on PubMed)

Other Identifiers

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DIM05

Identifier Type: -

Identifier Source: org_study_id

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