A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease - Full Text View

Sponsor:	Medivation, Inc.
Collaborator:	Pfizer
Information provided by:	Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00920946

Purpose

The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease.

Condition	Intervention	Phase
Huntington Disease	Drug: Dimebon Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Huntington Disease

Resource links provided by NLM:

Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Huntington's Disease

Drug Information available for: Dimebolin

U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:

A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
A comparison of the distributions of the CIBIC-plus (ADCS CGIC)in the Dimebon 20 mg TID treatment group and the placebo group [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the NPI [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the UHDRS'99 Total Motor Score [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Arms	Assigned Interventions
Placebo Comparator: Placebo	Other: Placebo Orally TID
Experimental: Dimebon	Drug: Dimebon 20 mg Dimebon orally TID

Detailed Description:

This study is a multicenter Phase 3, randomized, double-blind, placebo-controlled safety and efficacy study of Dimebon treatment in subjects with Huntington disease (HD). The study will evaluate Dimebon 20 mg three times daily (TID) administered orally (PO) for six months (26 weeks) compared with matching placebo TID for the primary safety and efficacy analyses. Safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, safety laboratory evaluations, and 12-lead electrocardiogram(ECG)assessments.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36
Have cognitive impairment as noted by the following:
1. A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and
2. A subjective assessment of cognitive impairment with decline from pre-HD levels by the Investigator after interviewing the subject and caregiver;
Are willing and able to give informed consent
Aged 30 years or older
Have a caregiver who assists/spends time with the subject at least five days per week for at least three hours per day and has intimate knowledge of the subject's cognitive, functional, and emotional states, and of the subject's personal care.

Exclusion Criteria:

Had onset of symptoms prior to age 18
Have any major medical illness or unstable medical condition within 180 days of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920946

Show 37 Study Locations

Sponsors and Collaborators

Medivation, Inc.

Pfizer

More Information

Additional Information:

Study website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Lynn Seely, MD / Chief Medical Officer, Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00920946 History of Changes
Other Study ID Numbers:	DIM20
Study First Received:	June 12, 2009
Last Updated:	April 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:

Huntington
Dimebon
HD
Huntingtin

Additional relevant MeSH terms:

Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias

Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012