An Extension Study to Evaluate the Long-Term Safety and Efficacy of Votoplam in Participants With Huntington's Disease (HD)
NCT ID: NCT06254482
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
144 participants
INTERVENTIONAL
2023-08-25
2029-07-16
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Votoplam 5 mg
Participants will receive Votoplam 5 mg tablets once daily orally for 48 months.
Votoplam
Votoplam will be administered per dose and schedule specified in the arm.
Votoplam 10 mg
Participants will receive votoplam 10 mg tablets once daily orally for 48 months.
Votoplam
Votoplam will be administered per dose and schedule specified in the arm.
Interventions
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Votoplam
Votoplam will be administered per dose and schedule specified in the arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
San Giovanni Rotondo, , Italy
Novartis Investigative Site
Leiden, , Netherlands
Novartis Investigative Site
Christchurch, , New Zealand
Novartis Investigative Site
Barakaldo, , Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Burgos, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
Cardiff, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
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Other Identifiers
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2023-504628-24-00
Identifier Type: OTHER
Identifier Source: secondary_id
CHTT227A12201
Identifier Type: OTHER
Identifier Source: secondary_id
PTC518-CNS-004-HD
Identifier Type: -
Identifier Source: org_study_id
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