Huntington Disease study: Pridopidine
Official title Pridopidine Phase 3 Study in Huntington's Disease
ClinicalTrials.gov ID: NCT07609108
What this study is testing
What is Pridopidine?
Pridopidine is an investigational oral medication being studied for Huntington’s disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will determine whether pridopidine can slow overall worsening of Huntington’s disease and its specific symptoms over one year, and it will assess the drug’s safety.
- Who it's for
- Adults diagnosed with Huntington’s disease.
- What's involved
- Participants will take a capsule of either pridopidine or a placebo twice daily for 12 months and visit the clinic six times for check‑ups and tests. After the first year, all participants will receive pridopidine for an additional two years and will have six more clinic visits.
- Time commitment
- The study lasts three years total: 12 months of double‑blind treatment followed by 24 months of open‑label pridopidine, with six clinic visits each year.
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 23 to 65
You may be able to join if
- 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...
- 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.
You likely can't join if
- Clinically significant cardiovascular disease (e.g. QTcF \>450 msec [males] or \>470 msec [females], arrhythmias, uncontrolled atrial fibrillation...
- 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.
See the full eligibility 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.
- 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...
- 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...
- Female participants who are pregnant, planning to become pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Wichita, Kansas, United States
- Golden Valley, Minnesota, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Krakow, Poland
- Aberdeen, United Kingdom
- Birmingham, United Kingdom
- Cardiff, United Kingdom
- Liverpool, United Kingdom
- Newcastle upon Tyne, 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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 23 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; La Jolla, California, United States; Wichita, Kansas, United States; Golden Valley, Minnesota, United States; New York, New York, United States; Durham, North Carolina, United States and 11 more locations. Enter your location above to see the nearest enrolling 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 ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.