Huntington DiseasePhase 3HORIZON PLUSNCT01085266
An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
A Phase 3 study testing Dimebon (latrepirdine) in people with Huntington Disease, run by Medivation, Inc..
Trial summary
An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with 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 (latrepirdine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Jun 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
- Successful completion of 26 weeks of blinded treatment in the HORIZON study
Who cannot join
- Any other medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information.
About this study
Official title: HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with Huntington disease.
- Conditions
- Huntington Disease
- Being tested
- Dimebon (latrepirdine)
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimebon (latrepirdine)Drug
| Study group | Role | What they receive |
|---|---|---|
| Dimebon (latrepirdine) | Experimental | Patients receive dimebon 10mg orally 3 times per day for 1 week and 20 mg orally 3 times per day thereafter. Receives: Drug: Dimebon (latrepirdine) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 362 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
- NCT01085266
- Sponsor's protocol ID
- DIM20EXT
- Acronym
- HORIZON PLUS
- Status last verified
- Oct 2016
- First submitted
- 10 Mar 2010
- Last updated
- 12 Oct 2016
- Results posted
- No
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
- HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
- ClinicalTrials.gov ID
- NCT01085266
- Acronym / sponsor ID
- HORIZON PLUS / DIM20EXT
- Conditions
- Huntington Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Medivation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- First posted
- 11 Mar 2010 (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.
An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with Huntington disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dimebon (latrepirdine) | Experimental | Drug: Dimebon (latrepirdine)Patients receive dimebon 10mg orally 3 times per day for 1 week and 20 mg orally 3 times per day thereafter. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Successful completion of 26 weeks of blinded treatment in the HORIZON study
Key exclusion criteria (1 listed)
- Any other medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information.
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 |
|---|---|---|
| Dimebon (latrepirdine) | Drug | Dimebon (latrepirdine) |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dimebon (latrepirdine) in people with Huntington Disease, run by Medivation, Inc..
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 1 inclusion and 1 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: stopped early, 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
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.