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Active (not recruiting) Phase 2 NCT06254482

An Extension Study to Evaluate the Long-Term Safety and Efficacy of Votoplam in Participants With Huntington's Disease (HD)

Phase 2 – studying effectiveness and dosage
Conditions: Huntington Disease

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
The primary goal of this study is to evaluate the long-term safety and pharmacodynamic effects of votoplam in participants with HD.
Description
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).
Who can participate
Inclusion Criteria: * Participant who has completed the Treatment Period in Study PTC518-CNS-002-HD. Exclusion Criteria: * Participants who have not previously completed the Treatment Period in Study PTC518-CNS-002-HD. Note: Other inclusion and exclusion criteria may apply.
Locations 9
Australia (1)
Novartis Investigative Site
Clayton
Canada (1)
Novartis Investigative Site
Ottawa
France (1)
Novartis Investigative Site
Angers
Germany (1)
Novartis Investigative Site
Berlin
Italy (1)
Novartis Investigative Site
Bologna
Netherlands (1)
Novartis Investigative Site
Leiden
New Zealand (1)
Novartis Investigative Site
Christchurch
Spain (1)
Novartis Investigative Site
Barakaldo
United Kingdom (1)
Novartis Investigative Site
Birmingham
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
25 Years
Healthy volunteers
No
Start date
25.08.2023
Completion date
16.07.2029
Registry ID
NCT06254482
Source
anzctr
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