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A Phase 2b, Double-Blind, Randomized Extension Study to Evaluate the Long-Term Safety and Efficacy of Votoplam in Participants With Huntington’s Disease
EU CTIS ID: 2023-504628-24-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
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
- 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.
You likely can't join if
- Individuals are not eligible to participate in this study if they have not previously completed the Treatment Period in Study PTC518-CNS-002-HD.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- United Kingdom
- Australia
- Canada
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 New Zealand; United Kingdom; Australia; Canada. 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.