NCT07609108ClinicalTrials.gov

Pridopidine Phase 3 Study in Huntington's Disease

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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

שלב 3דרושים 400 משתתפים66 אתרים12 מדינות

קטגוריות

נוירולוגיה44%מחלות נדירות וגנטיות44%פסיכיאטריה ובריאות הנפש13%

רשום במרשם אחד

ClinicalTrials.govNCT07609108פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני 3 ימים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2026-05-27; recorded start 2026-07-01
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 2 other studies in this databaseCounted from the lead sponsor named in the record (Prilenia)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre0/8
Single site, or site count not stated
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 400 participants (target), run at 66 sites, across 12 countries.

How this score is built

Enrolment25/40
400 participants (target)
Site count0/25
Site count not stated in the record
Country count0/15
Country count not stated in the record
Planned duration9/10
Planned over about 49 months
Sponsor scale1/10
Prilenia has led 3 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

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.

This Phase 3 study consists of two study periods, a randomized, double-blind, placebo-controlled 1-year study period and a 2-year open-label extension (OLE) period. The study assesses the effect of pridopidine 45 mg twice daily on HD in participants who are not using antidopaminergic medications (ADMs) at study start. Main objectives of the study will be to assess the effect of pridopidine on clinical progression of HD within 1 year and to evaluate the effect of pridopidine on functional capacity, cognition, motor function, quality of life (QoL), and speech in participants with HD within 1 year. The target population in this study are adult participants (age 23-65, inclusive) with adult-onset HD (onset of signs and symptoms and a diagnosis ≥21 years of age). Eligible participants have not been using ADMs for at least 6 months prior to the screening visit. In case ADM treatment is deemed necessary by the treating physician during the study, specific ADMs and doses may be initiated. Female participants who are pregnant, planning to become pregnant or breastfeeding are not allowed to enter the study. The treatment period will start with a 2-week titration period of once-daily treatment (1 capsule of pridopidine or placebo taken orally in the morning). From Day 15 onwards, all participants will take the study drug twice daily: in the morning and in the afternoon. Treatment will continue for an additional 50 weeks. The placebo-controlled study period includes 6 in-clinic visits and 5 telephone visits (safety calls) during the 1-year treatment period. The placebo-controlled study period will be followed by a 2-year OLE period. During the OLE period, all eligible participants will receive pridopidine. The OLE will consist of a 2-year treatment period, including an initial 2-week (re)titration period for all participants at pridopidine once daily and a maintenance period of 102 weeks with pridopidine twice daily. The blinding of the original treatment assignment will be maintained for all participants and study personnel during the OLE period. A total of 6 in-clinic visits and 6 telephone visits (safety calls) are planned during the 2-year OLE period.

מצבים רפואיים

Huntington Disease

זכאות

זכאות
מין	הכול
גילאים	23 Years – 65 Years
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 3
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	QUADRUPLE (4)
גיוס	דרושים 400 משתתפים

נותן חסות ושותפים

Prilenia נותן חסות
Ferrer Internacional S.A. שותפים

זרועות והתערבויות

PridopidineEXPERIMENTAL
During the titration period (2 weeks), pridopidine 45 mg capsules will be taken orally once daily (in the morning) for 2 weeks. Afterwards, pridopidine 45 mg capsules will be taken orally twice daily (in the morning and in the afternoon; 7-10 hours apart) for 50 weeks.
PlaceboPLACEBO_COMPARATOR
During the titration period (2 weeks), matched placebo hard gelatin capsules will be taken once daily (in the morning) for 2 weeks. Afterwards, placebo capsules will be taken twice daily (in the morning and in the afternoon; 7-10 hours apart) for 50 weeks.

התערבויות

תרופה Placebo
Matched placebo hard gelatin capsule
תרופה Pridopidine
Pridopidine hard gelatin capsule

מדדי תוצאה

מדד תוצאה ראשוני
Change in Composite Unified Huntington's Disease Rating Scale (cUHDRS)
cUHDRS is a combined score to assess disease progression in HD. It includes TFC, TMS, SDMT, and SWR: Total Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. Higher score = better outcome. Best score=13. Worst score=0. Total Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Higher score = worse outcome. Best score=0. Worst score= 124. Stroop Word Reading (SWR) measures attention and mental flexibility. Participant reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome. Best score=100. Worst score=0. Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to match numbers with symbols. Scores = correct answers in 90 sec. Higher score = better outcome. Best score=120. Worst score=0. Total integrated cUHDRS scale range: -7.6 to 24.8. The higher, the better.
מסגרת זמן Change from Baseline to Week 52
מדד תוצאה משני
Change in Total Functional Capacity (TFC) score
Total Functional Capacity (TFC) tests the capacity to maintain domestic chores, activities of daily living, finances, care level, and occupation. Scores from 0 - 13. Higher score = better outcome.
מסגרת זמן Change from Baseline to Week 52
מדד תוצאה משני
Change in Quantitative Motor (Q-Motor) Finger Tapping Inter-Onset Interval (FT-IOI) mean
Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Higher score = worse outcome.
מסגרת זמן Change from Baseline to Week 52
מדד תוצאה משני
Change in Stroop Word Reading (SWR) score
Stroop Word Reading (SWR) measures attention and mental flexibility. Participant reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome.
מסגרת זמן Change from Baseline to Week 52

תאריכים

תאריכים
תאריך התחלה	1 ביולי 2026 (בפועל)
סיום ראשוני	1 ביוני 2028 (משוער)
סיום	1 ביוני 2030 (משוער)
פורסם לראשונה	27 במאי 2026 (בפועל)
עודכן לאחרונה	17 בספטמבר 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	מאי 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

5 אתרים מגייסים

Belgium

Belgium
מתקן	עיר	מדינה או אזור	מצב
Hopital Erasme	Anderlecht		טרם מגייס
Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert		טרם מגייס

Canada

Canada
מתקן	עיר	מדינה או אזור	מצב
University of Calgary	Calgary	Alberta	טרם מגייס
University of Alberta	Edmonton	Alberta	טרם מגייס
Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec	טרם מגייס
North York General Hospital	Toronto	Ontario	טרם מגייס
University of British Columbia	Vancouver	British Columbia	טרם מגייס

Czechia

Czechia
מתקן	עיר	מדינה או אזור	מצב
Vseobecna Fakultni Nemocnice V Praze	Prague		טרם מגייס

France

France
מתקן	עיר	מצב
Centre Hospitalier Universitaire D'Angers	Angers	טרם מגייס
CHU Henri Mondor (APHP)	Créteil	טרם מגייס
Centre Hospitalier Universitaire Grenoble Alpes	La Tronche	טרם מגייס
Centre Hospitalier Regional De Marseille	Marseille	טרם מגייס

Germany

Germany
מתקן	עיר	מצב
Universitaetsklinikum Aachen AöR	Aachen	טרם מגייס
Katholisches Klinikum Bochum gGmbH	Bochum	טרם מגייס
Universitätsklinikum Erlangen	Erlangen	טרם מגייס
George-Huntington-Institut GmbH	Münster	טרם מגייס
Isar Amper Klinikum	Taufkirchen	טרם מגייס
Universitaetsklinikum Ulm AöR	Ulm	טרם מגייס

Italy

Italy
מתקן	עיר	מצב
Azienda Unita Sanitaria Locale Di Bologna	Bologna	טרם מגייס
IRCCS Istituto Auxologico Italiano	Milan	טרם מגייס
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	טרם מגייס
Azienda Ospedale Università di Padova	Padova	טרם מגייס
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	טרם מגייס
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	טרם מגייס

Netherlands

Netherlands
מתקן	עיר	מדינה או אזור	מצב
Leids Universitair Medisch Centrum (LUMC)	Leiden		טרם מגייס

Poland

Poland
מתקן	עיר	מדינה או אזור	מצב
Krakowska Akademia Neurologii Sp. z o.o.	Krakow		טרם מגייס
Wojskowy Instytut Medycyny Lotniczej	Warsaw		טרם מגייס

Portugal

Portugal
מתקן	עיר	מצב
Unidade Local De Saude De Coimbra E.P.E	Coimbra	טרם מגייס
Unidade Local De Saude De Santa Maria E.P.E.	Lisbon	טרם מגייס
Unidade Local De Saude De Santo Antonio E.P.E.	Porto	טרם מגייס
CNS Saude Lda.	Torres Vedras	טרם מגייס

Spain

Spain
מתקן	עיר	מצב
Hospital Universitario De Cruces	Barakaldo	טרם מגייס
Hospital De La Santa Creu I Sant Pau	Barcelona	טרם מגייס
Hospital Universitario Ramon Y Cajal	Madrid	טרם מגייס
Hospital Universitario Central De Asturias	Oviedo	טרם מגייס
Hospital Universitario Virgen del Rocío	Seville	טרם מגייס

United Kingdom

United Kingdom
מתקן	עיר	מצב
NHS Grampian	Aberdeen	טרם מגייס
Birmingham and Solihull Mental Health Foundation NHS Trust	Birmingham	טרם מגייס
Cardiff University	Cardiff	טרם מגייס
The Walton Centre NHS Foundation Trust	Liverpool	טרם מגייס
CNTW NHS Foundation Trust	Newcastle upon Tyne	טרם מגייס

United States

United States
מתקן	עיר	מדינה או אזור	מצב
Johns Hopkins University	Baltimore	Maryland	טרם מגייס
The University of Alabama at Birmingham	Birmingham	Alabama	טרם מגייס
University of Miami-U Health Boca Raton	Boca Raton	Florida	טרם מגייס
University of Vermont Medical Center	Burlington	Vermont	טרם מגייס
Massachusetts General Hospital	Charlestown	Massachusetts	טרם מגייס
Rush University Medical Center	Chicago	Illinois	טרם מגייס
Northwestern University	Chicago	Illinois	טרם מגייס
University of Cincinnati	Cincinnati	Ohio	טרם מגייס
Cleveland Clinic	Cleveland	Ohio	טרם מגייס

16 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

7 באוגוסט 2026
המצב השתנה
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
7 באוגוסט 2026
הגיוס נפתח
Recruitment opened
NOT_YET_RECRUITINGRECRUITING
7 באוגוסט 2026
אתר נוסף
66 sites added (66 total)
066

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07609108