Tests votoplam in people with early symptomatic Huntington's disease
Compares votoplam with placebo in adults with early Huntington's disease.
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Bunkyo Ku, Kashihara, and Sagamihara, JapanSee the 3 sitesAlso in 32 other countries, 165 sites
- Trial code
- NCT07326709
- EU 2025-522227-99-00
- U1111-1332-7661
- Registry title
- A Study to Investigate the Efficacy, Safety and Tolerability of Votoplam in Participants With Huntington's Disease
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 770 people, planned
- Started
- 24 Mar 2026
- Expected to end
- 30 Apr 2030
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Votoplam (blinded)
- Placebo
- Record updated
- 22 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with early symptomatic Huntington's disease, confirmed by a gene test, who can walk on their own.
- Age
- 21 to 70 years old
- Sex
- Men and women
- Disease stage
- Early symptomatic Huntington's disease, who can walk (ambulatory). Scores on the UHDRS scales (IS ≥90, TFC = 13, TMS 7-25) and CAP100 ≥ 70 are required.
- Earlier treatment
- Cannot have had gene therapy, cell transplantation or any other experimental brain surgery for Huntington's disease.
- Biomarker or test result
- Huntington's disease confirmed by a gene test, with a CAG repeat length of 40 or above, known before screening.
Main reasons for not taking part
- Active viral hepatitis
- Immunodeficiency disease, including a positive HIV test
- Heart rhythm or ECG problems that carry a significant safety risk
- Women who could become pregnant and are not using highly effective contraception
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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; o 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
- 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
- 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
- Pregnant or nursing (breastfeeding) women; Other protocol defined inclusion/exclusion criteria may apply
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 70 years old?
Where in Japan
Also in 32 other countries, 165 sites
- Bunkyo Ku, TokyoHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- Kashihara, NaraHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- Sagamihara, KanagawaHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
About the trial
What the trial wants to find out
The purpose is to assess safety and tolerability of votoplam and to determine whether votoplam slows disease progression in patients with early symptomatic Huntington's disease (HD) compared to the control arm.
Read full original descriptionShow less
HTT227 - current compound code (former code is PTC518 from PTC Therapeutics), HTT227 is Novartis code under Novartis sponsorship.
The 2 groups in the trial
- VotoplamTreatment being tested
Votoplam (blinded) taken orally, randomized in a 3:2 ratio (Votoplam: Placebo)
Treatment: Votoplam (blinded)
- PlaceboPlacebo, for comparison
Placebo (blinded) taken orally, randomized in a 3:2 ratio (Votoplam: Placebo)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Randomized, Placebo-controlled, Double-blind Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Votoplam in Participants With Huntington's Disease
- Plain-language title
- Tests votoplam in people with early symptomatic Huntington's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07326709, who can take part
- Record updated
- 22 September 2026