Huntington DiseaseNCT06343220
Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research
An observational study of Huntington Disease, run by Huntington Study Group at 1 site in United States.
Trial summary
The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 22 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Must either have HD or be at risk for having HD.
Who may be able to join
- Participants must either have HD or be at risk for having HD
- Participants must be 18 years of age or older
- Participants must live in the United States
- Inclusion of participants will not be based on race, gender, or ethnicity.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted.
Read the detailed description
The Project AWARE 2.0 Survey will be offered to HD families via HSG's online platform called myHDstory®. The survey will obtain input and knowledge about their feelings, attitudes, and beliefs concerning clinical research and the process by which HD studies are communicated and conducted. Project AWARE 2.0 is intended to provide the HD research community with the insight and tools to help (a) improve prospective research participants' awareness, willingness, and ability to participate in clinical research for HD; and (b) design clinical studies and trials in the future.
- Conditions
- Huntington Disease
- Keywords
- HSG, HD, Observational
- Medical subject headings
- Huntington Disease, Charcot-Marie-Tooth Disease, Axonal, Type 2A2
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine awareness
To examine prospective research participants' awareness, willingness, and ability to participate in clinical research for HD.
Measured: December 2024
Provide the HD research community with the insight.
Provide the HD research community with insight to design clinical studies and trials in the future.
Measured: December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start10 Apr 2024
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huntington Study Group
- Sponsor type
- Research network
- Collaborators
- Hoffmann-La Roche, Neurotargeting LLC
- Responsible party
- Sponsor
- Investigators
- Amy Brown, MD, MS, Principal investigator, HSG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343220
- Sponsor's protocol ID
- AWARE 2.0
- Status last verified
- Dec 2025
- First submitted
- 26 Mar 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted. Answers to these questions will provide valuable information to the HD research community when designing and conducting drug trials and observational studies.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research
- ClinicalTrials.gov ID
- NCT06343220
- Acronym / sponsor ID
- AWARE 2.0
- Conditions
- Huntington Disease
- Keywords
- HSG, HD, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Huntington Study GroupResearch network
- Collaborators
- Hoffmann-La Roche, Neurotargeting LLC
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 2 Apr 2024 (actual)
- 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 Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted.
Detailed description
The Project AWARE 2.0 Survey will be offered to HD families via HSG's online platform called myHDstory®. The survey will obtain input and knowledge about their feelings, attitudes, and beliefs concerning clinical research and the process by which HD studies are communicated and conducted. Project AWARE 2.0 is intended to provide the HD research community with the insight and tools to help (a) improve prospective research participants' awareness, willingness, and ability to participate in clinical research for HD; and (b) design clinical studies and trials in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Must either have HD or be at risk for having HD.
Key inclusion criteria (4 listed)
- Participants must either have HD or be at risk for having HD
- Participants must be 18 years of age or older
- Participants must live in the United States
- Inclusion of participants will not be based on race, gender, or ethnicity.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Examine awareness
Time frame: December 2024
To examine prospective research participants' awareness, willingness, and ability to participate in clinical research for HD.
Provide the HD research community with the insight.
Time frame: December 2024
Provide the HD research community with insight to design clinical studies and trials in the future.
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 23 Dec 2025.
- Individual participant dataSharing planned: Yes. The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted. Answers to these questions will provide valuable information to the HD research community when designing and conducting drug trials and observational studies.
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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.
Amy Brown, MD, MS principal investigator
HSG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by Huntington Study Group at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Examine awareness (time frame: December 2024). 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?
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 23 Dec 2025.