Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE September 15, 2017
First Posted Date  ICMJE September 28, 2017
Last Update Posted Date November 1, 2017
Actual Study Start Date  ICMJE October 9, 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
metabolite mass [ Time Frame: at baseline ]
by chromatography and mass spectrometry
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03296176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolomic Study in Huntington's Disease (METABO-HD)
Official Title  ICMJE Metabolomic Study in Huntington's Disease
Brief Summary The purpose of this project is to study Huntington's disease by metabolomic approach.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Huntington Disease
Intervention  ICMJE Biological: blood sample
blood sample for metabolome analyse
Study Arms  ICMJE
  • Experimental: presymptomatic
    Intervention: Biological: blood sample
  • Experimental: symptomatic
    Intervention: Biological: blood sample
  • controls
    Intervention: Biological: blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2017)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Christophe Verny, PU-PH 0241355615 Chverny@chu-angers.fr
Contact: Dominique Bonneau, PU-PH 0241355615 dobonneau@chu-angers.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03296176
Other Study ID Numbers  ICMJE 49RC17_0086
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Angers
Study Sponsor  ICMJE University Hospital, Angers
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christophe Verny, PU-PH University Hospital, Angers
PRS Account University Hospital, Angers
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP