Huntington DiseasePhase 3PRECISE-HDNCT07609108
Pridopidine Phase 3 Study in Huntington's Disease
A Phase 3 study testing Pridopidine in people with Huntington Disease, run by Prilenia at 66 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 65 years
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Pridopidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 66 sitesin 12 countries
- Study dates
- 1 Jul 2026to Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
66 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
66 sites in 12 countries
United States25 sites, 25 recruiting
- Not yet recruiting
Johns Hopkins University
Baltimore, Maryland, 60612
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
- Not yet recruiting
University of Miami-U Health Boca Raton
Boca Raton, Florida, 33486
- Not yet recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
- Not yet recruiting
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
- Not yet recruiting
Northwestern University
Chicago, Illinois, 60611
- Not yet recruiting
Rush University Medical Center
Chicago, Illinois, 60612
- Not yet recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
The Ohio State University
Columbus, Ohio, 43221
- Recruiting
Duke University
Durham, North Carolina, 27705
- Not yet recruiting
University of Florida (Norman Fixel Institute for Neurological Diseases)
Gainesville, Florida, 32608
- Recruiting
Struthers Parkinson's Center / Health Partners Institute
Golden Valley, Minnesota, 55427
- Recruiting
UT Health, Houston, McGovern Medical School
Houston, Texas, 77030
- Not yet recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66103
- Not yet recruiting
EvergreenHealth Research Department
Kirkland, Washington, 98034
- Recruiting
University of California, San Diego
La Jolla, California, 92037
Alex Scott, 858-249-0569, als074@health.ucsd.edu
- Not yet recruiting
UCLA Medical Center
Los Angeles, California, 90095
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
- Recruiting
Columbia University
New York, New York, 10032
- Not yet recruiting
Oregon Health and Science University (OHSU)
Portland, Oregon, 97239
- Not yet recruiting
UC Davis Medical Center
Sacramento, California, 95817
- Recruiting
University of Washington
Seattle, Washington, 98195
- Not yet recruiting
Georgetown University
Washington D.C., District of Columbia, 20007
- Recruiting
Hereditary Neurological Disease Centre
Wichita, Kansas, 67226
Gregory Suter, 316-609-3020, gregory@hndcentre.com
Germany6 sites, 6 recruiting
- Not yet recruiting
Universitaetsklinikum Aachen AöR
Aachen
- Not yet recruiting
Katholisches Klinikum Bochum gGmbH
Bochum
- Not yet recruiting
Universitätsklinikum Erlangen
Erlangen
- Not yet recruiting
George-Huntington-Institut GmbH
Münster
- Not yet recruiting
Isar Amper Klinikum
Taufkirchen
- Not yet recruiting
Universitaetsklinikum Ulm AöR
Ulm
Italy6 sites, 6 recruiting
- Not yet recruiting
Azienda Unita Sanitaria Locale Di Bologna
Bologna
- Not yet recruiting
IRCCS Istituto Auxologico Italiano
Milan
- Not yet recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples
- Not yet recruiting
Azienda Ospedale Università di Padova
Padova
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
- Not yet recruiting
Casa Sollievo Della Sofferenza
San Giovanni Rotondo
Canada5 sites, 5 recruiting
- Not yet recruiting
University of Calgary
Calgary, Alberta
- Not yet recruiting
University of Alberta
Edmonton, Alberta
- Not yet recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec
- Not yet recruiting
North York General Hospital
Toronto, Ontario
- Not yet recruiting
University of British Columbia
Vancouver, British Columbia
Spain5 sites, 5 recruiting
- Not yet recruiting
Hospital Universitario De Cruces
Barakaldo
- Not yet recruiting
Hospital De La Santa Creu I Sant Pau
Barcelona
- Not yet recruiting
Hospital Universitario Ramon Y Cajal
Madrid
- Not yet recruiting
Hospital Universitario Central De Asturias
Oviedo
- Not yet recruiting
Hospital Universitario Virgen del Rocío
Seville
United Kingdom5 sites, 5 recruiting
- Recruiting
NHS Grampian
Aberdeen
- Recruiting
Birmingham and Solihull Mental Health Foundation NHS Trust
Birmingham
- Recruiting
Cardiff University
Cardiff
- Recruiting
The Walton Centre NHS Foundation Trust
Liverpool
- Recruiting
CNTW NHS Foundation Trust
Newcastle upon Tyne
France4 sites, 4 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire D'Angers
Angers
- Not yet recruiting
CHU Henri Mondor (APHP)
Créteil
- Not yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche
- Not yet recruiting
Centre Hospitalier Regional De Marseille
Marseille
Portugal4 sites, 4 recruiting
- Not yet recruiting
Unidade Local De Saude De Coimbra E.P.E
Coimbra
- Not yet recruiting
Unidade Local De Saude De Santa Maria E.P.E.
Lisbon
- Not yet recruiting
Unidade Local De Saude De Santo Antonio E.P.E.
Porto
- Not yet recruiting
CNS Saude Lda.
Torres Vedras
Belgium2 sites, 2 recruiting
- Not yet recruiting
Hopital Erasme
Anderlecht
- Not yet recruiting
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert
Poland2 sites, 2 recruiting
- Recruiting
Krakowska Akademia Neurologii Sp. z o.o.
Krakow
- Not yet recruiting
Wojskowy Instytut Medycyny Lotniczej
Warsaw
Czechia1 site, 1 recruiting
- Not yet recruiting
Vseobecna Fakultni Nemocnice V Praze
Prague
Netherlands1 site, 1 recruiting
- Not yet recruiting
Leids Universitair Medisch Centrum (LUMC)
Leiden
About this study
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)
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Huntington Disease
- Being tested
- Pridopidine, Placebo
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PridopidineDrug
Pridopidine hard gelatin capsule
PlaceboDrug
Matched placebo hard gelatin capsule
| Study group | Role | What they receive |
|---|---|---|
| Pridopidine | Experimental | 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. Receives: Drug: Pridopidine |
| Placebo | Placebo 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Week 52
Secondary outcomes (3)
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.
Measured: Change from Baseline to Week 52
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.
Measured: Change from Baseline to Week 52
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.
Measured: Change from Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jul 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1), double-blind, placebo-controlled 1-year study period, followed by a 2-year open-label extension (OLE) period. During the OLE, all participants will receive pridopidine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prilenia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferrer Internacional S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609108
- Sponsor's protocol ID
- PL101-HD302/ FNP253-CT-2502
- Other IDs
- 2026-526093-16-00
- Acronym
- PRECISE-HD
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07609108
- Acronym / sponsor ID
- PRECISE-HD / PL101-HD302/ FNP253-CT-2502
- Conditions
- Huntington Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- PrileniaIndustry (pharma, biotech, devices)
- Collaborators
- Ferrer Internacional S.A.
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized (1:1), double-blind, placebo-controlled 1-year study period, followed by a 2-year open-label extension (OLE) period. During the OLE, all participants will receive pridopidine.
| Arm | Type | Receives |
|---|---|---|
| Pridopidine | Experimental | Drug: PridopidineDuring 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. |
| Placebo | Placebo comparator | Drug: PlaceboDuring 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. |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PridopidinePridopidine hard gelatin capsule | Drug | Pridopidine |
| PlaceboMatched placebo hard gelatin capsule | Drug | Placebo |
Primary outcome
Change in Composite Unified Huntington's Disease Rating Scale (cUHDRS)
Time frame: Change from Baseline to Week 52
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.
3 secondary outcomes
Change in Total Functional Capacity (TFC) score
Time frame: Change from Baseline to Week 52
Change in Quantitative Motor (Q-Motor) Finger Tapping Inter-Onset Interval (FT-IOI) mean
Time frame: Change from Baseline to Week 52
Change in Stroop Word Reading (SWR) score
Time frame: Change from Baseline to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
66 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pridopidine in people with Huntington Disease, run by Prilenia at 66 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Germany, Italy, Canada, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prilenia Medical Information (018575745755, MedInfo@prilenia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Composite Unified Huntington's Disease Rating Scale (cUHDRS) (time frame: Change from Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.