Frequency of Selected Single Nucleotide Polymorphisms in Huntington Disease Gene Expansion Carriers

NCT ID: NCT06667414

Last Updated: 2025-11-10

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

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-02

Study Completion Date

2028-09-24

Brief Summary

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For participation in this epidemiological study, a single-day visit at the study site is required. Participants will be recruited from Huntington Disease clinics, and they will be asked to answer questions regarding their demographics, including sex, age, race and ethnicity, and their medical and medication history. At the end of the visit, a blood sample will be drawn to allow testing with a sequencing assay that is specifically designed for phasing single nucleotide polymorphisms (SNPs) on the wild-type Huntington (wtHTT) and mutant Huntington (mHTT) alleles.

Detailed Description

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Conditions

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Huntington Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Participants Who Are Huntington Disease Gene Expansion Carriers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Have signed the Informed Consent Form (ICF)
* Aged 25 to 60 years, inclusive, at the time of signing the ICF
* Confirmation of Huntington Disease (HD) gene expansion mutation carrier status
* Confirmation of Total Functional Capacity (TFC) ≥9 and Total Motor Score (TMS) \>6 within 12 months prior to signing the ICF
* Ability to tolerate blood draws

Exclusion Criteria

* None
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Uab Medicine

Birmingham, Alabama, United States

Site Status COMPLETED

Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status RECRUITING

University of California San Diego

La Jolla, California, United States

Site Status COMPLETED

University of California Davis Medical System

Sacramento, California, United States

Site Status COMPLETED

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, United States

Site Status COMPLETED

University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status COMPLETED

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status COMPLETED

John Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

EvergreenHealth Investigational Drug Services

Kirkland, Washington, United States

Site Status RECRUITING

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, , Argentina

Site Status RECRUITING

Calvary Health Care Bethlehem

Caulfield South, New South Wales, Australia

Site Status RECRUITING

Westmead Hospital

Westmead, New South Wales, Australia

Site Status RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status RECRUITING

Graylands Hospital

Mount Claremont, Western Australia, Australia

Site Status RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

University of British Columbia Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Centricity Research

Halifax, Nova Scotia, Canada

Site Status RECRUITING

North York General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

McGill University

Montreal, Quebec, Canada

Site Status RECRUITING

Rigshospitalet, Hukommelsesklinikken

København Ø, , Denmark

Site Status RECRUITING

Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie

Berlin, , Germany

Site Status RECRUITING

St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni

Bochum, , Germany

Site Status RECRUITING

Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

Erlangen, , Germany

Site Status RECRUITING

Universitätsklinikum Ulm

Ulm, , Germany

Site Status RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

Site Status RECRUITING

Universita Degli Studi Di Firenze

Florence, Tuscany, Italy

Site Status RECRUITING

Auckland DHB - Neurlogy Department

Auckland, , New Zealand

Site Status RECRUITING

New Zealand Brain Research Institute

Christchurch, , New Zealand

Site Status RECRUITING

Wellington Hospital

Wellington, , New Zealand

Site Status RECRUITING

Szpital Sw. Wojciecha

Gda?sk, , Poland

Site Status RECRUITING

Wojskowy Instytut Medycyny Lotniczej

Warsaw, , Poland

Site Status RECRUITING

Unidade Local de Saude de Santa Maria, E.P.E. - Hospital de Santa Maria

Lisbon, , Portugal

Site Status RECRUITING

CNS - Campus Neurológico

Torres Vedras, , Portugal

Site Status RECRUITING

Hospital Universitario de Badajoz

Badajoz, , Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario de Burgos. Servicio de Neurología

Burgos, , Spain

Site Status RECRUITING

Hospital Ramon y Cajal

Madrid, , Spain

Site Status RECRUITING

Birmingham and Solihull Mental Health Foundation NHS Trust

Birmingham, , United Kingdom

Site Status RECRUITING

Addenbrookes Hospital

Cambridge, , United Kingdom

Site Status RECRUITING

National Hospital For Neurology and Neurosurgery

London, , United Kingdom

Site Status RECRUITING

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Canada Denmark Germany Italy New Zealand Poland Portugal Spain United Kingdom

Central Contacts

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Reference Study ID Number: WE45491 https://forpatients.roche.com/

Role: CONTACT

Phone: 888-662-6728 (U.S. Only)

Email: [email protected]

Other Identifiers

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WE45491

Identifier Type: -

Identifier Source: org_study_id