A Study of the Novel Drug Dimebon in Patients With Huntington's Disease - Full Text View

Purpose

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.

Condition	Intervention	Phase
Huntington's Disease	Other: Placebo Drug: Dimebon	Phase II

Genetics Home Reference related topics:

chorea-acanthocytosis familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics:

Huntington's Disease

ChemIDplus related topics:

Dimebolin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Medivation:

Primary Outcome Measures:

To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
To assess the pharmacokinetics of Dimebon. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	July 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Other: Placebo Placebo TID x 90 days
2: Experimental Dimebon	Drug: Dimebon Dimebon 20 mg TID x 90 days

Eligibility

Ages Eligible for Study:	29 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497159

Locations


United States, New York
	Huntington Study Group
	Rochester, New York, United States, 14620

Sponsors and Collaborators

Medivation

Huntington Study Group

Investigators


Principal Investigator:	Karl Kieburtz, MD, MPH	Huntington Study Group, University of Rochester

More Information

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. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	Clinical Trial Coordination Center, University of Rochester ( Karl Kieburtz, MD )
Study ID Numbers:	DIM05
First Received:	July 3, 2007
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00497159
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Medivation:

Trial of Dimebon to treat patients with mild-to-moderate Huntington's disease.

Study placed in the following topic categories:

Ganglion Cysts

Huntington disease

Basal Ganglia Diseases

Central Nervous System Diseases

Brain Diseases

Neurodegenerative Diseases

Dyskinesias

Cognition Disorders

Chorea

Delirium, Dementia, Amnestic, Cognitive Disorders

Heredodegenerative Disorders, Nervous System

Genetic Diseases, Inborn

Mental Disorders

Movement Disorders

Dementia

Huntington Disease

Delirium

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	Medivation Huntington Study Group
Information provided by:	Medivation
ClinicalTrials.gov Identifier:	NCT00497159