Back to resultsMetabolomic Study in Huntington's Disease (METABO-HD)
Primary Purpose
Huntington Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional other trial for Huntington Disease
Eligibility Criteria
Inclusion Criteria:
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
- 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
Exclusion Criteria for all groups:
- participation in another therapeutic trial (3 months exclusion period)
- pregnancy and breastfeeding
- persons deprived of their liberty by judicial or administrative decision
Sites / Locations
- CHU AngersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
presymptomatic
symptomatic
controls
Arm Description
Outcomes
Primary Outcome Measures
metabolite mass
by chromatography and mass spectrometry
Secondary Outcome Measures
Full Information
NCT ID
NCT03296176
First Posted
September 15, 2017
Last Updated
October 30, 2017
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT03296176
Brief Title
Metabolomic Study in Huntington's Disease (METABO-HD)
Official Title
Metabolomic Study in Huntington's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this project is to study Huntington's disease by metabolomic approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
presymptomatic
Arm Type
Experimental
Arm Title
symptomatic
Arm Type
Experimental
Arm Title
controls
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
blood sample for metabolome analyse
Primary Outcome Measure Information:
Title
metabolite mass
Description
by chromatography and mass spectrometry
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria for all groups:
participation in another therapeutic trial (3 months exclusion period)
pregnancy and breastfeeding
persons deprived of their liberty by judicial or administrative decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Verny, PU-PH
Phone
0241355615
Email
Chverny@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Bonneau, PU-PH
Phone
0241355615
Email
dobonneau@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Verny, PU-PH
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VERNY
Phone
02.41.35.78.56
Ext
33
Email
chverny@chu-angers.fr
12. IPD Sharing Statement
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Metabolomic Study in Huntington's Disease (METABO-HD)
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