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RECRUITING

NCT07609108

PHASE3

Pridopidine Phase 3 Study in Huntington's Disease

Sponsor: Prilenia

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if pridopidine can slow the clinical decline of Huntington's Disease (HD) in adult participants. It will also inform about the safety of pridopidine. The main questions the study aims to answer are: Does pridopidine slow the overall worsening of HD over 1 year? Does pridopidine slow the worsening of specific aspects of HD over 1 year, namely the clinical progression, the ability to perform daily life activities (functional capacity), the mind's ability to process information (cognition), working of the muscles (motor function), and quality of life? Researchers will compare the drug pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works better than placebo to treat HD. During the first year of the study, participants will have the same chance to receive either pridopidine or placebo. Participants will: Take 1 pridopidine or placebo capsule twice daily for 12 months. Visit the clinic 6 times within 1 year for checkups and tests. All participants who complete this 1-year placebo-controlled study period will roll over into an additional 2-year study period during which all participants will receive pridopidine treatment, including participants who had received placebo during the first year. During this additional 2-year treatment period participants will visit the clinic a total of 6 times for checkups and tests.

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Huntington's Disease (HD)

Key Details

Gender

All

Age Range

23 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-07-01

Completion Date

2030-06

Last Updated

2026-08-07

Healthy Volunteers

Conditions

Huntington Disease

Interventions

DRUG

Pridopidine

Pridopidine hard gelatin capsule

DRUG

Placebo

Matched placebo hard gelatin capsule

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.

Locations (66)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California, San Diego

La Jolla, California, United States

UCLA Medical Center

Los Angeles, California, United States

UC Davis Medical Center

Sacramento, California, United States

Georgetown University

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

University of Miami-U Health Boca Raton

Boca Raton, Florida, United States

University of Florida (Norman Fixel Institute for Neurological Diseases)

Gainesville, Florida, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Hereditary Neurological Disease Centre

Wichita, Kansas, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Struthers Parkinson's Center / Health Partners Institute

Golden Valley, Minnesota, United States

Columbia University

New York, New York, United States

Duke University

Durham, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Health and Science University (OHSU)

Portland, Oregon, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Health, Houston, McGovern Medical School

Houston, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

EvergreenHealth Research Department

Kirkland, Washington, United States

University of Washington

Seattle, Washington, United States

Hopital Erasme

Anderlecht, Belgium

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

North York General Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Vseobecna Fakultni Nemocnice V Praze

Prague, Czechia

Centre Hospitalier Universitaire D'Angers

Angers, France

CHU Henri Mondor (APHP)

Créteil, France

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, France

Centre Hospitalier Regional De Marseille

Marseille, France

Universitaetsklinikum Aachen AöR

Aachen, Germany

Katholisches Klinikum Bochum gGmbH

Bochum, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

George-Huntington-Institut GmbH

Münster, Germany

Isar Amper Klinikum

Taufkirchen, Germany

Universitaetsklinikum Ulm AöR

Ulm, Germany

Azienda Unita Sanitaria Locale Di Bologna

Bologna, Italy

IRCCS Istituto Auxologico Italiano

Milan, Italy

Azienda Ospedaliera Universitaria Federico II Di Napoli

Naples, Italy

Azienda Ospedale Università di Padova

Padova, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Italy

Leids Universitair Medisch Centrum (LUMC)

Leiden, Netherlands

Krakowska Akademia Neurologii Sp. z o.o.

Krakow, Poland

Wojskowy Instytut Medycyny Lotniczej

Warsaw, Poland

Unidade Local De Saude De Coimbra E.P.E

Coimbra, Portugal

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

Lisbon, Portugal

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

Porto, Portugal

CNS Saude Lda.

Torres Vedras, Portugal

Hospital Universitario De Cruces

Barakaldo, Spain

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital Universitario Central De Asturias

Oviedo, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

NHS Grampian

Aberdeen, United Kingdom

Birmingham and Solihull Mental Health Foundation NHS Trust

Birmingham, United Kingdom

Cardiff University

Cardiff, United Kingdom

The Walton Centre NHS Foundation Trust

Liverpool, United Kingdom

CNTW NHS Foundation Trust

Newcastle upon Tyne, United Kingdom