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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
The primary goal of this study is to evaluate the long-term safety and pharmacodynamic effects of votoplam in participants with HD.
Participants who completed the Treatment Period in the parent Phase 2a Study PTC518-CNS-002-HD (NCT05358717), fulfilled the enrollment criteria, and chose to enroll in this extension study will undergo baseline evaluations and be assessed for 54 additional months. All participants will receive active votoplam in this extension study. Participants who received votoplam in the parent Study PTC518-CNS-002-HD will continue at the same dose level they received in that study in a blinded fashion (5, 10 milligrams \[mg\]). Participants who received placebo in the parent Study PTC518-CNS-002-HD will be allocated to a votoplam dose level according to the same dosing group in which they were previously randomized (5, 10 mg).
Age
25 - No limit years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Clayton, Australia
Novartis Investigative Site
Westmead, Australia
Novartis Investigative Site
Innsbruck, Austria
Novartis Investigative Site
Ottawa, Canada
Novartis Investigative Site
Angers, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Münster, Germany
Start Date
August 25, 2023
Primary Completion Date
July 16, 2029
Completion Date
July 16, 2029
Last Updated
November 21, 2025
144
ACTUAL participants
Votoplam
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT04012411
NCT06414967
NCT05822908
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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