NCT03296176

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

November 1, 2017

Status Verified

September 1, 2017

Enrollment Period

1.9 years

First QC Date

September 15, 2017

Last Update Submit

October 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • metabolite mass

    by chromatography and mass spectrometry

    at baseline

Study Arms (3)

presymptomatic

EXPERIMENTAL
Biological: blood sample

symptomatic

EXPERIMENTAL
Biological: blood sample

controls

OTHER
Biological: blood sample

Interventions

blood sampleBIOLOGICAL

blood sample for metabolome analyse

controlspresymptomaticsymptomatic

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy and breastfeeding
  • persons deprived of their liberty by judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49000, France

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christophe Verny, PU-PH

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe Verny, PU-PH

CONTACT

Dominique Bonneau, PU-PH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2017

First Posted

September 28, 2017

Study Start

October 9, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

November 1, 2017

Record last verified: 2017-09

Locations