Is Caffeine an Environmental Modifier in Huntington's Disease?

NCT ID: NCT03034122

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-11

Study Completion Date

2024-04-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Huntington Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* HD mutation carriers (\>36 CAG)
* premanifest (total motor UHDRS \< 5)
* estimated time to diagnosis between 3 and 10 years
* adults older than 21 years (in order to exclude juvenile patients who begin the disease before 21 years)
* informed consent signed
* with a social protection

Exclusion Criteria

* MRI contraindication
* pregnant and lactating women
* People under guardianship, trusteeship, deprive of freedom
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clémence Simonin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Amiens

Amiens, , France

Site Status

CHU de Angers

Angers, , France

Site Status

CHU Pellegrin

Bordeaux, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

Hôpital Roger Salengro, CHRU

Lille, , France

Site Status

CHU Montpellier

Montpellier, , France

Site Status

CHU de Nancy

Nancy, , France

Site Status

AH-HP La Pitié-Salpétrière

Paris, , France

Site Status

AH-HP, Hôpital Henri Mondor

Paris, , France

Site Status

CHU Purpan

Toulouse, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-A00892-49

Identifier Type: OTHER

Identifier Source: secondary_id

2015_67

Identifier Type: -

Identifier Source: org_study_id