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Status unknownNCT03296176Updated Nov 1, 2017

Metabolomic Study in Huntington's Disease (METABO-HD)

An interventional study of blood sample in Huntington Disease, sponsored by University Hospital, Angers. Status unknown at 1 site in France. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

The purpose of this project is to study Huntington's disease by metabolomic approach.

02

Conditions studied

  • Huntington Disease

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03

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    presymptomatic

    Biological: blood sample

  • Experimental
    symptomatic

    Biological: blood sample

  • Other
    controls

    Biological: blood sample

Interventions

  • Biologicalblood sample

    blood sample for metabolome analyse

05

What researchers measure

Primary outcomes

  1. metabolite mass

    by chromatography and mass spectrometry

    Time frame: at baseline

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT03296176
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Oct 9, 2017
Primary completion
Sep 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Nov 1, 2017

Study contacts

Christophe Verny, PU-PH
Contact
Chverny@chu-angers.fr
0241355615
Dominique Bonneau, PU-PH
Contact
dobonneau@chu-angers.fr
0241355615
Christophe Verny, PU-PH
principal investigator · University Hospital, Angers

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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