Huntington DiseasePhase 3HORIZONNCT00920946
A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
A Phase 3 study testing Dimebon in people with Huntington Disease, run by Medivation, Inc. at 37 sites in 7 countries.
Trial summary
The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Dimebon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 403 participants
- Where
- 37 sitesin 7 countries
- Study dates
- Jul 2009to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
United States24 sites
Study site
Boise, Idaho, 83702
Study site
Charlestown, Massachusetts, 02129
Study site
Cleveland, Ohio, 44195
Study site
Columbus, Ohio, 43210
Study site
Davis, California, 95616
Study site
Durham, North Carolina, 27705
Study site
Gainsville, Florida, 32610
Study site
Golden Valley, Minnesota, 55427
Study site
Indianapolis, Indiana, 46202
Study site
Irvine, California, 92697
Study site
Kansas City, Kansas, 66160
Study site
La Jolla, California, 92161
Study site
Miami, Florida, 33136
Study site
Milwaukee, Wisconsin, 53226
Study site
New York, New York, 10032
Study site
Philadelphia, Pennsylvania, 19107
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Portland, Oregon, 97201
Study site
Rochester, New York, 14620
Study site
San Francisco, California, 94143
Study site
Scottsdale, Arizona, 85259
Study site
St Louis, Missouri, 63110
Study site
Wichita, Kansas, 67206
Study site
Winstom-Salem, North Carolina, 27157
Germany4 sites
Study site
Aachen
Study site
Bochum
Study site
Hamburg
Study site
Oberer Eslebberg, Ulm
Australia3 sites
Study site
Melbourne, Victoria
Study site
Perth
Study site
Wentworthville, New South Wales
Canada3 sites
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Vancouver, British Columbia
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease
The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease.
Read the 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.
- Conditions
- Huntington Disease
- Being tested
- Dimebon, Placebo
- Keywords
- Huntington, Dimebon, HD, Huntingtin
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DimebonDrug
20 mg Dimebon orally TID
PlaceboOther
Orally TID
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Dimebon | Experimental | Not described Receives: Drug: Dimebon |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE
Measured: 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
Measured: Week 26
Secondary outcomes (3)
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the NPI
Measured: 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
Measured: 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
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920946
- Sponsor's protocol ID
- DIM20
- Acronym
- HORIZON
- Status last verified
- Oct 2016
- First submitted
- 12 Jun 2009
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23108692
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease
- ClinicalTrials.gov ID
- NCT00920946
- Acronym / sponsor ID
- HORIZON / DIM20
- Conditions
- Huntington Disease
- Keywords
- Huntington, Dimebon, HD, Huntingtin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Medivation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- First posted
- 15 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| Dimebon | Experimental | Drug: Dimebon |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36
- Have cognitive impairment as noted by the following:
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimebon20 mg Dimebon orally TID | Drug | Dimebon |
| PlaceboOrally TID | Other | Placebo |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Derived from this study: PubMed 23108692HORIZON 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.
- Study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dimebon in people with Huntington Disease, run by Medivation, Inc. at 37 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Germany, Australia, Canada, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00920946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.