CTIS2023-504628-24-00RecruitingPhase 1
A Phase 2b, Double-Blind, Randomized Extension Study to Evaluate the Long-Term Safety and Efficacy of PTC518 in Participants With Huntington’s Disease - PTC518-CNS-004-HD
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- PTC Therapeutics Inc.
- Enrollment
- 358
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Individuals are not eligible to participate in this study if they have not previously completed the Treatment Period in Study PTC518-CNS-002-HD.
Investigators
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