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Hope for Huntington's: new drug aims to slow decline in major trial

NCT ID NCT07609108

Disease control Sponsor: Prilenia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This study tests whether the drug pridopidine can slow the worsening of Huntington's disease (HD) in adults. About 400 participants will take either pridopidine or a placebo twice daily for one year, then everyone can receive pridopidine for two more years. The goal is to see if the drug helps maintain daily function, thinking, and movement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

23 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult-onset HD (onset of signs and symptoms and a clinical diagnosis at ≥21 years of age). * A diagnosis based on clinical features and the presence of ≥40 CAG repeats in the huntingtin (HTT) gene confirmed by historical laboratory quanitified results or by a diagnostic test at Screening. * Diagnostic confidence level (DCL) of 4 (DCL=4 unequivocal motor signs, ≥99% confidence) on the standardized motor exam Total Motor Score (TMS). * Total Functional Capacity (TFC) score of ≥7 at Screening and Baseline. * Cytosine-Adenine-Guanine (CAG)-Age Product (CAP)100 score ≥95 at Screening. * Independence Scale (IS) score ≤90% at Screening. * Total Motor Score (TMS) of ≥20 at Screening and Baseline. * Not using ADMs (VMAT2i and neuroleptics/antipsychotics) for at least 6 months prior to Screening visit. Importantly, it is not encouraged to discontinue the participants' ADM treatment solely for enrollment in the current trial. Exclusion Criteria: * Clinically significant cardiovascular disease (e.g. QTcF \>450 msec \[males\] or \>470 msec \[females\], arrhythmias, uncontrolled atrial fibrillation, or congenital long QT syndrome), seizure history ≤5 years, significant neurological disorders (e.g. intracranial pathology or cerebrovascular events), active/recent malignancy (unless localized and resolved), or any serious or uncontrolled systemic disease (e.g. hepatic, renal, respiratory, endocrine, infectious \[HBV, HCV, HIV\], or psychiatric) that may pose safety risk or interfere with participation. * Severe hepatic or renal impairment. * Any mutant huntingtin (mHTT) lowering therapy in the past year. * Medications that prolong QT interval, taken within 4 weeks of the baseline visit. * Use of pridopidine within 6 weeks or 5 half-lives before the screening visit. * Previous participation in intracranial gene therapy study. * Laboratory values that fall outside of the central laboratory's reference range at Screening and are considered clinically significantly abnormal by the Investigator and affect the participant's suitability to participate in the study or put the participant at risk if he/she enters the study in the Investigator's opinion. * Female participants who are pregnant, planning to become pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

Huntington disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Huntington disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    66 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Azienda Ospedale Università di Padova

    NOT_YET_RECRUITING

    Padova, Italy

  • Azienda Ospedaliera Universitaria Federico II Di Napoli

    NOT_YET_RECRUITING

    Naples, Italy

  • Azienda Unita Sanitaria Locale Di Bologna

    NOT_YET_RECRUITING

    Bologna, Italy

  • Birmingham and Solihull Mental Health Foundation NHS Trust

    NOT_YET_RECRUITING

    Birmingham, United Kingdom

  • CHU Henri Mondor (APHP)

    NOT_YET_RECRUITING

    Créteil, France

  • CNS Saude Lda.

    NOT_YET_RECRUITING

    Torres Vedras, Portugal

  • CNTW NHS Foundation Trust

    NOT_YET_RECRUITING

    Newcastle upon Tyne, United Kingdom

  • Cardiff University

    NOT_YET_RECRUITING

    Cardiff, United Kingdom

  • Casa Sollievo Della Sofferenza

    NOT_YET_RECRUITING

    San Giovanni Rotondo, Italy

  • Centre Hospitalier Regional De Marseille

    NOT_YET_RECRUITING

    Marseille, France

  • Centre Hospitalier Universitaire D'Angers

    NOT_YET_RECRUITING

    Angers, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    NOT_YET_RECRUITING

    La Tronche, France

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    NOT_YET_RECRUITING

    Montreal, Quebec, Canada

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cliniques Universitaires Saint-Luc

    NOT_YET_RECRUITING

    Woluwe-Saint-Lambert, Belgium

  • Columbia University

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Duke University

    NOT_YET_RECRUITING

    Durham, North Carolina, 27705, United States

  • EvergreenHealth Research Department

    NOT_YET_RECRUITING

    Kirkland, Washington, 98034, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    NOT_YET_RECRUITING

    Roma, Italy

  • George-Huntington-Institut GmbH

    NOT_YET_RECRUITING

    Münster, Germany

  • Georgetown University

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Hereditary Neurological Disease Centre

    RECRUITING

    Wichita, Kansas, 67226, United States

  • Hopital Erasme

    NOT_YET_RECRUITING

    Anderlecht, Belgium

  • Hospital De La Santa Creu I Sant Pau

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Hospital Universitario Central De Asturias

    NOT_YET_RECRUITING

    Oviedo, Spain

  • Hospital Universitario De Cruces

    NOT_YET_RECRUITING

    Barakaldo, Spain

  • Hospital Universitario Ramon Y Cajal

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Universitario Virgen del Rocío

    NOT_YET_RECRUITING

    Seville, Spain

  • IRCCS Istituto Auxologico Italiano

    NOT_YET_RECRUITING

    Milan, Italy

  • Isar Amper Klinikum

    NOT_YET_RECRUITING

    Taufkirchen, Germany

  • Johns Hopkins University

    NOT_YET_RECRUITING

    Baltimore, Maryland, 60612, United States

  • Katholisches Klinikum Bochum gGmbH

    NOT_YET_RECRUITING

    Bochum, Germany

  • Krakowska Akademia Neurologii Sp. z o.o.

    NOT_YET_RECRUITING

    Krakow, Poland

  • Leids Universitair Medisch Centrum (LUMC)

    NOT_YET_RECRUITING

    Leiden, Netherlands

  • Massachusetts General Hospital

    NOT_YET_RECRUITING

    Charlestown, Massachusetts, 02129, United States

  • NHS Grampian

    NOT_YET_RECRUITING

    Aberdeen, United Kingdom

  • North York General Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, Canada

  • Northwestern University

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University (OHSU)

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Rush University Medical Center

    NOT_YET_RECRUITING

    Chicago, Illinois, 60612, United States

  • Struthers Parkinson's Center / Health Partners Institute

    NOT_YET_RECRUITING

    Golden Valley, Minnesota, 55427, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43221, United States

  • The University of Alabama at Birmingham

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35294, United States

  • The Walton Centre NHS Foundation Trust

    NOT_YET_RECRUITING

    Liverpool, United Kingdom

  • UC Davis Medical Center

    NOT_YET_RECRUITING

    Sacramento, California, 95817, United States

  • UCLA Medical Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • UT Health, Houston, McGovern Medical School

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Unidade Local De Saude De Coimbra E.P.E

    NOT_YET_RECRUITING

    Coimbra, Portugal

  • Unidade Local De Saude De Santa Maria E.P.E.

    NOT_YET_RECRUITING

    Lisbon, Portugal

  • Unidade Local De Saude De Santo Antonio E.P.E.

    NOT_YET_RECRUITING

    Porto, Portugal

  • Universitaetsklinikum Aachen AöR

    NOT_YET_RECRUITING

    Aachen, Germany

  • Universitaetsklinikum Ulm AöR

    NOT_YET_RECRUITING

    Ulm, Germany

  • University of Alberta

    NOT_YET_RECRUITING

    Edmonton, Alberta, Canada

  • University of British Columbia

    NOT_YET_RECRUITING

    Vancouver, British Columbia, Canada

  • University of Calgary

    NOT_YET_RECRUITING

    Calgary, Alberta, Canada

  • University of California, San Diego

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Cincinnati

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Florida (Norman Fixel Institute for Neurological Diseases)

    NOT_YET_RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Kansas Medical Center

    NOT_YET_RECRUITING

    Kansas City, Kansas, 66103, United States

  • University of Miami-U Health Boca Raton

    NOT_YET_RECRUITING

    Boca Raton, Florida, 33486, United States

  • University of Vermont Medical Center

    NOT_YET_RECRUITING

    Burlington, Vermont, 05401, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Erlangen

    NOT_YET_RECRUITING

    Erlangen, Germany

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37212, United States

  • Vseobecna Fakultni Nemocnice V Praze

    NOT_YET_RECRUITING

    Prague, Czechia

  • Wojskowy Instytut Medycyny Lotniczej

    NOT_YET_RECRUITING

    Warsaw, Poland

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Other studies related to the condition(s) this trial covers.