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RECRUITING Phase 3 ClinicalTrials.gov

Pridopidine Phase 3 Study in Huntington's Disease

Sponsor: Prilenia • ClinicalTrials.gov ID: NCT07609108

Registry updated: 2026-10-16
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Description

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.

Interventions

  • Pridopidine (Drug)
    Pridopidine hard gelatin capsule
  • Placebo (Drug)
    Matched placebo hard gelatin capsule

Eligibility criteria

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.

Conditions

Huntington Disease

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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