Huntington DiseaseNCT03296176
Metabolomic Study in Huntington's Disease (METABO-HD)
A study testing blood sample in people with Huntington Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this project is to study Huntington's disease by metabolomic approach. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2017to Sep 2019
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all groups:
- age between 20 and 70 years
- signature of the informed consent
- covered by social security
- For presymptomatic group:
- positive genetic test with CAG repeat length ≥ 37 in HTT gene
Show all 11Show fewer
- Unified Huntington Disease Rating Scale ≤ 5
- For symptomatic group:
- positive genetic test with CAG repeat length ≥ 37 in HTT gene
- The Unified Huntington's Disease Rating Scale motor score ≥ 6
- The Total Functional Capacity score ≥ 11
Who cannot join
- participation in another therapeutic trial (3 months exclusion period)
- pregnancy and breastfeeding
- persons deprived of their liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Angers
Angers, 49000
VERNY, 02.41.35.78.56 ext. 33, chverny@chu-angers.fr
About this study
Official title: Metabolomic Study in Huntington's Disease
The purpose of this project is to study Huntington's disease by metabolomic approach.
- Conditions
- Huntington Disease
- Being tested
- blood sample
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
blood sample for metabolome analyse
| Study group | Role | What they receive |
|---|---|---|
| presymptomatic | Experimental | Not described Receives: Biological: blood sample |
| symptomatic | Experimental | Not described Receives: Biological: blood sample |
| controls | Other | Not described Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolite mass
by chromatography and mass spectrometry
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start9 Oct 2017
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
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.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Christophe Verny, PU-PH, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296176
- Sponsor's protocol ID
- 49RC17_0086
- Status last verified
- Sep 2017
- First submitted
- 15 Sep 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Study in Huntington's Disease
- ClinicalTrials.gov ID
- NCT03296176
- Acronym / sponsor ID
- 49RC17_0086
- Conditions
- Huntington Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 28 Sep 2017 (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 purpose of this project is to study Huntington's disease by metabolomic approach.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| presymptomatic | Experimental | Biological: blood sample |
| symptomatic | Experimental | Biological: blood sample |
| controls | Other | Biological: blood sample |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- age between 20 and 70 years
- signature of the informed consent
- covered by social security
- positive genetic test with CAG repeat length ≥ 37 in HTT gene
- Unified Huntington Disease Rating Scale ≤ 5
Key exclusion criteria (3 listed)
- participation in another therapeutic trial (3 months exclusion period)
- pregnancy and breastfeeding
- persons deprived of their liberty by judicial or administrative decision
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 |
|---|---|---|
| blood sampleblood sample for metabolome analyse | Biological | controls, presymptomatic, symptomatic |
Primary outcome
metabolite mass
Time frame: at baseline
by chromatography and mass spectrometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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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.
Christophe Verny, PU-PH principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Huntington Disease, run by University Hospital, Angers at 1 site in France.
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 11 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Nov 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe Verny, PU-PH (0241355615, Chverny@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolite mass (time frame: at baseline). 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 1 Nov 2017.