NCT06254482Active, not recruitingPhase 2
A Phase 2b, Double-Blind, Randomized Extension Study to Evaluate the Long-Term Safety and Efficacy of Votoplam in Participants With Huntington’s Disease
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Jun 2026
Brief summary (registry, in English)
Safety - Evaluate the long-term safety of Votoplam in participants with Huntington’s disease (HD) Efficacy - Evaluate the pharmacodynamic effects of Votoplam through the reduction in blood total huntingtin (tHTT) levels
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 172 (estimated)
- First submitted
- 19 May 2023
- Start date
- 31 Oct 2023
- Lead sponsor
- Novartis Pharma AG
- Diseases
- Huntington's disease
- NCT number
- NCT06254482
- EU CT number
- 2023-504628-24-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 172
- 16 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals are not eligible to participate in this study if they have not previously completed the Treatment Period in Study PTC518-CNS-002-HD.
Who the study is looking for
- Ambulatory male or female participant aged 25 years and older, inclusive, who has completed the Treatment Period in Study PTC518-CNS-002-HD
- Participant is willing and able to provide informed consent and comply with all protocol requirements
- Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception during dosing and for 6 months after stopping the study medication.
- Sexually active and fertile males must use a condom during intercourse while taking study drug and for 6 months after stopping study drug and should neither father a child nor donate sperm in this period. A condom is required to be used also by vasectomized men in order to prevent potential delivery of the drug via seminal fluid.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Active, not recruiting |
| George-Huntington-Institut GmbH Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire D Angers Coordinator of this site? Confirm its status | Angers Cedex 9 | France | Active, not recruiting |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Active, not recruiting |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Active, not recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.