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)

En reclutamientoAdmite participantes ahora, según el registro.

Contactar con este estudio

En resumen

Fase 3400 participantes buscados66 centros12 países

Categorías

Neurología44%Enfermedades raras y genéticas44%Psiquiatría y salud mental13%

Registrado en 1 registro

ClinicalTrials.govNCT07609108Abrir este registro en ClinicalTrials.govSincronizado hace 3 días

Un mismo estudio puede estar registrado en varios registros. Lo mostramos una sola vez y enlazamos con todos los registros que tenemos.

La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

¿Le interesa este estudio?

Iniciar sesión o cree una cuenta para registrar su interés y seguir este estudio.

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.

Resumen

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.

Afecciones

Huntington Disease

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	23 Years – 65 Years
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	QUADRUPLE (4)
Inscripción	400 participantes buscados

Patrocinador y colaboradores

Prilenia Patrocinador
Ferrer Internacional S.A. Colaboradores

Grupos e intervenciones

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.

Intervenciones

Fármaco Placebo
Matched placebo hard gelatin capsule
Fármaco Pridopidine
Pridopidine hard gelatin capsule

Variables de resultado

Variable de resultado principal
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.
Plazo Change from Baseline to Week 52
Variable de resultado secundaria
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.
Plazo Change from Baseline to Week 52
Variable de resultado secundaria
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.
Plazo Change from Baseline to Week 52
Variable de resultado secundaria
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.
Plazo Change from Baseline to Week 52

Fechas

Fechas
Fecha de inicio	1 de julio de 2026 (real)
Finalización principal	1 de junio de 2028 (estimada)
Finalización	1 de junio de 2030 (estimada)
Primera publicación	27 de mayo de 2026 (real)
Última actualización	17 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	mayo de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

5 centros están en reclutamiento

Belgium

Belgium
Centro	Ciudad	Estado o región	Estado
Hopital Erasme	Anderlecht		Aún no recluta
Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert		Aún no recluta

Canada

Canada
Centro	Ciudad	Estado o región	Estado
University of Calgary	Calgary	Alberta	Aún no recluta
University of Alberta	Edmonton	Alberta	Aún no recluta
Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec	Aún no recluta
North York General Hospital	Toronto	Ontario	Aún no recluta
University of British Columbia	Vancouver	British Columbia	Aún no recluta

Czechia

Czechia
Centro	Ciudad	Estado o región	Estado
Vseobecna Fakultni Nemocnice V Praze	Prague		Aún no recluta

France

France
Centro	Ciudad	Estado
Centre Hospitalier Universitaire D'Angers	Angers	Aún no recluta
CHU Henri Mondor (APHP)	Créteil	Aún no recluta
Centre Hospitalier Universitaire Grenoble Alpes	La Tronche	Aún no recluta
Centre Hospitalier Regional De Marseille	Marseille	Aún no recluta

Germany

Germany
Centro	Ciudad	Estado
Universitaetsklinikum Aachen AöR	Aachen	Aún no recluta
Katholisches Klinikum Bochum gGmbH	Bochum	Aún no recluta
Universitätsklinikum Erlangen	Erlangen	Aún no recluta
George-Huntington-Institut GmbH	Münster	Aún no recluta
Isar Amper Klinikum	Taufkirchen	Aún no recluta
Universitaetsklinikum Ulm AöR	Ulm	Aún no recluta

Italy

Italy
Centro	Ciudad	Estado
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Aún no recluta
IRCCS Istituto Auxologico Italiano	Milan	Aún no recluta
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Aún no recluta
Azienda Ospedale Università di Padova	Padova	Aún no recluta
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Aún no recluta
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Aún no recluta

Netherlands

Netherlands
Centro	Ciudad	Estado o región	Estado
Leids Universitair Medisch Centrum (LUMC)	Leiden		Aún no recluta

Poland

Poland
Centro	Ciudad	Estado o región	Estado
Krakowska Akademia Neurologii Sp. z o.o.	Krakow		Aún no recluta
Wojskowy Instytut Medycyny Lotniczej	Warsaw		Aún no recluta

Portugal

Portugal
Centro	Ciudad	Estado
Unidade Local De Saude De Coimbra E.P.E	Coimbra	Aún no recluta
Unidade Local De Saude De Santa Maria E.P.E.	Lisbon	Aún no recluta
Unidade Local De Saude De Santo Antonio E.P.E.	Porto	Aún no recluta
CNS Saude Lda.	Torres Vedras	Aún no recluta

Spain

Spain
Centro	Ciudad	Estado
Hospital Universitario De Cruces	Barakaldo	Aún no recluta
Hospital De La Santa Creu I Sant Pau	Barcelona	Aún no recluta
Hospital Universitario Ramon Y Cajal	Madrid	Aún no recluta
Hospital Universitario Central De Asturias	Oviedo	Aún no recluta
Hospital Universitario Virgen del Rocío	Seville	Aún no recluta

United Kingdom

United Kingdom
Centro	Ciudad	Estado
NHS Grampian	Aberdeen	Aún no recluta
Birmingham and Solihull Mental Health Foundation NHS Trust	Birmingham	Aún no recluta
Cardiff University	Cardiff	Aún no recluta
The Walton Centre NHS Foundation Trust	Liverpool	Aún no recluta
CNTW NHS Foundation Trust	Newcastle upon Tyne	Aún no recluta

United States

United States
Centro	Ciudad	Estado o región	Estado
Johns Hopkins University	Baltimore	Maryland	Aún no recluta
The University of Alabama at Birmingham	Birmingham	Alabama	Aún no recluta
University of Miami-U Health Boca Raton	Boca Raton	Florida	Aún no recluta
University of Vermont Medical Center	Burlington	Vermont	Aún no recluta
Massachusetts General Hospital	Charlestown	Massachusetts	Aún no recluta
Rush University Medical Center	Chicago	Illinois	Aún no recluta
Northwestern University	Chicago	Illinois	Aún no recluta
University of Cincinnati	Cincinnati	Ohio	Aún no recluta
Cleveland Clinic	Cleveland	Ohio	Aún no recluta

En el registro figuran 16 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

7 de agosto de 2026
Estado modificado
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
7 de agosto de 2026
Reclutamiento abierto
Recruitment opened
NOT_YET_RECRUITINGRECRUITING
7 de agosto de 2026
Centro añadido
66 sites added (66 total)
066

Registro: ClinicalTrials.gov · NCT########

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