A clinical trial to learn more about the effects of votoplam (HTT227) in people with Huntington’s disease
EU CTIS ID: 2025-522227-99-00
What this study is testing
To assess the effect of votoplam compared to control arm on HD progression by measuring the change in the composite Unified Huntington’s Disease Rating Scale (cUHDRS).
- 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
- Signed informed consents must be obtained prior to participation in the study
- Ambulatory male or female participants between 21 to 70 years of age, inclusive, on the day of Informed Consent signature
- Genetically confirmed HD diagnosis with a cytosine-adenine-guanine (CAG) repeat length of 40 or above. Participants must have prior genetic confirmation and known CAG repeat length obtained prior to screening.
- • Meets all of the following criteria: • UHDRS IS score ≥90 • UHDRS TFC score = 13 • UHDRS TMS score = 7-25, inclusive • CAP100 ≥ 70 Calculation: CAP = Age at study entry × (CAG length − 30) / 6.49
You likely can't join if
- • History of gene therapy or cell transplantation or any other experimental brain surgery for the treatment of HD
- • Serologic evidence for active viral hepatitis as indicated by: • positive anti-HBc IgM • positive anti-HBc IgG confirmed by positive HBsAg and/or HBV DNA • positive HCV ab test confirmed by positive HCV RNA • Immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. WOCBP are excluded unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 8 months after stopping study treatment.
- Pregnant or nursing (breastfeeding) women
- • History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants such as: • Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker • History of familial long QT syndrome or known family history of Torsade de Pointes
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Japan
- Brazil
- Switzerland
- United States
- Taiwan
- China
- Saudi Arabia
- Canada
- Mexico
- Israel
- Argentina
- Australia
- Korea, Republic of
- Colombia
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 - 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 United Kingdom; Japan; Brazil; Switzerland; United States; Taiwan and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.