Pridopidine Phase 3 Study to establish clinical impact and Safety in Huntington's Disease.
EU CTIS ID: 2026-526093-16-00
What this study is testing
To assess the effect of pridopidine on clinical progression in participants with HD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Adult participants aged 23-65 at screening, inclusive.
- 2. Adult-onset HD (onset of signs and symptoms and a clinical diagnosis at ≥21 years of age).
- 3. A diagnosis based on clinical features and the presence of ≥40 CAG repeats in the huntingtin (HTT) gene confirmed by historical laboratory quantified results or by a diagnostic test at screening.
- 4. Diagnostic confidence level of 4 (DCL=4 unequivocal motor signs, ≥99% confidence) on the standardized motor exam Total Motor Score (TMS).
- 5. Total Functional Capacity (TFC) score of ≥7 at screening and baseline.
- 6. Cytosine-Adenine-Guanine (CAG)-Age Product (CAP)100 score ≥95 at screening.
You likely can't join if
- 1. Clinically significant cardiovascular disease (e.g. QTcF >450 msec [males] or >470 msec [females], arrhythmias, uncontrolled atrial fibrillation, or congenital long QT syndrome), seizures 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.
- 2. Severe hepatic or renal impairment.
- 3. Any mutant huntingtin (mHTT) lowering therapy in the past year.
- 4. Medications that prolong QT interval, taken within 4 weeks of the baseline visit.
- 5. Use of pridopidine within 6 weeks or 5 half-lives before the screening visit.
- 6. Previous participation in intracranial gene therapy study.
See the full eligibility criteria
- 1. Adult participants aged 23-65 at screening, inclusive.
- 2. Adult-onset HD (onset of signs and symptoms and a clinical diagnosis at ≥21 years of age).
- 3. A diagnosis based on clinical features and the presence of ≥40 CAG repeats in the huntingtin (HTT) gene confirmed by historical laboratory quantified results or by a diagnostic test at screening.
- 4. Diagnostic confidence level of 4 (DCL=4 unequivocal motor signs, ≥99% confidence) on the standardized motor exam Total Motor Score (TMS).
- 5. Total Functional Capacity (TFC) score of ≥7 at screening and baseline.
- 6. Cytosine-Adenine-Guanine (CAG)-Age Product (CAP)100 score ≥95 at screening.
- 7. Independence Scale (IS) score ≤90% at screening.
- 8. Total Motor Score (TMS) score of ≥20 at screening and baseline.
- 9. 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.
- 1. Clinically significant cardiovascular disease (e.g. QTcF >450 msec [males] or >470 msec [females], arrhythmias, uncontrolled atrial fibrillation, or congenital long QT syndrome), seizures 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.
- 2. Severe hepatic or renal impairment.
- 3. Any mutant huntingtin (mHTT) lowering therapy in the past year.
- 4. Medications that prolong QT interval, taken within 4 weeks of the baseline visit.
- 5. Use of pridopidine within 6 weeks or 5 half-lives before the screening visit.
- 6. Previous participation in intracranial gene therapy study.
- 7. 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.
- 8. Female participants who are pregnant, planning to become pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Poland
- United States
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poland; United States; Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.