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

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ClinicalTrials.gov Identifier: NCT03296176
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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

Condition or disease Intervention/treatment Phase
Huntington Disease Biological: blood sample Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Metabolomic Study in Huntington's Disease
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: presymptomatic Biological: blood sample
blood sample for metabolome analyse

Experimental: symptomatic Biological: blood sample
blood sample for metabolome analyse

controls Biological: blood sample
blood sample for metabolome analyse




Primary Outcome Measures :
  1. metabolite mass [ Time Frame: at baseline ]
    by chromatography and mass spectrometry



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296176


Contacts
Contact: Christophe Verny, PU-PH 0241355615 Chverny@chu-angers.fr
Contact: Dominique Bonneau, PU-PH 0241355615 dobonneau@chu-angers.fr

Locations
France
CHU Angers Recruiting
Angers, France, 49000
Contact: VERNY    02.41.35.78.56 ext 33    chverny@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Christophe Verny, PU-PH University Hospital, Angers

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03296176     History of Changes
Other Study ID Numbers: 49RC17_0086
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias