A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease (HORIZON)

This study has been completed.

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Medivation, Inc.

ClinicalTrials.gov Identifier:

NCT00920946

First received: June 12, 2009

Last updated: October 11, 2016

Last verified: October 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

June 12, 2009

Last Updated Date

October 11, 2016

Start Date ^ICMJE

July 2009

Primary Completion Date

July 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]
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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00920946 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
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 ]
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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease

Official Title ^ICMJE

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Huntington Disease

Intervention ^ICMJE

Drug: Dimebon
20 mg Dimebon orally TID
Other: Placebo
Orally TID

Study Arms

Placebo Comparator: Placebo
Intervention: Other: Placebo
Experimental: Dimebon
Intervention: Drug: Dimebon

Publications *

HORIZON Investigators of the Huntington Study Group and European Huntington's Disease Network. A randomized, double-blind, placebo-controlled study of latrepirdine in patients with mild to moderate Huntington disease. JAMA Neurol. 2013 Jan;70(1):25-33. doi: 10.1001/2013.jamaneurol.382.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

403

Completion Date

Not Provided

Primary Completion Date

July 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

30 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Canada, Denmark, Germany, Sweden, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00920946

Other Study ID Numbers ^ICMJE

DIM20

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Medivation, Inc.

Study Sponsor ^ICMJE

Medivation, Inc.

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

Not Provided

PRS Account

Medivation, Inc.

Verification Date

October 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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