Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00920946




Registration number
NCT00920946
Ethics application status
Date submitted
12/06/2009
Date registered
15/06/2009
Date last updated
12/10/2016

Titles & IDs
Public title
A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease
Secondary ID [1] 0 0
DIM20
Universal Trial Number (UTN)
Trial acronym
HORIZON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dimebon
Other interventions - Placebo

Placebo Comparator: Placebo -

Experimental: Dimebon -


Treatment: Drugs: Dimebon
20 mg Dimebon orally TID

Other interventions: Placebo
Orally TID
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE
Timepoint [1] 0 0
Week 26
Primary outcome [2] 0 0
A comparison of the distributions of the CIBIC-plus (ADCS CGIC)in the Dimebon 20 mg TID treatment group and the placebo group
Timepoint [2] 0 0
Week 26
Secondary outcome [1] 0 0
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the NPI
Timepoint [1] 0 0
Week 26
Secondary outcome [2] 0 0
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL
Timepoint [2] 0 0
Week 26
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 26

Eligibility
Key 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.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
403
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Wentworthville
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Wentworthville
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Denmark
State/province [19] 0 0
Copenhagen
Country [20] 0 0
Germany
State/province [20] 0 0
Ulm
Country [21] 0 0
Germany
State/province [21] 0 0
Aachen
Country [22] 0 0
Germany
State/province [22] 0 0
Bochum
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Sweden
State/province [24] 0 0
Stockholm
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medivation, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00920946
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00920946