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

Primary Purpose

Huntington Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dimebon
Placebo
Sponsored by
Medivation, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington Disease focused on measuring Huntington, Dimebon, HD, Huntingtin

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Dimebon

Arm Description

Outcomes

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
A comparison of the distributions of the CIBIC-plus (ADCS CGIC)in the Dimebon 20 mg TID treatment group and the placebo group

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
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL
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

Full Information

First Posted
June 12, 2009
Last Updated
October 11, 2016
Sponsor
Medivation, Inc.
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00920946
Brief Title
A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
Acronym
HORIZON
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivation, Inc.
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
Huntington, Dimebon, HD, Huntingtin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
403 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Dimebon
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dimebon
Intervention Description
20 mg Dimebon orally TID
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Orally TID
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36 Have cognitive impairment as noted by the following: A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and 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
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92161
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67206
Country
United States
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
City
Winstom-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Wentworthville
State/Province
New South Wales
Country
Australia
City
Melbourne
State/Province
Victoria
Country
Australia
City
Perth
Country
Australia
City
Vancouver
State/Province
British Columbia
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Copenhagen
Country
Denmark
City
Oberer Eslebberg
State/Province
Ulm
Country
Germany
City
Aachen
Country
Germany
City
Bochum
Country
Germany
City
Hamburg
Country
Germany
City
Stockholm
Country
Sweden
City
Birmingham
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23108692
Citation
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.
Results Reference
derived
Links:
URL
http://www.horizontrial.com
Description
Study website

Learn more about this trial

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

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