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Активно (без набиране) Фаза 2 NCT06254482

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Huntington Disease

Спонсор: Novartis Pharmaceuticals

Налично на: БГ
Обобщение
The primary goal of this study is to evaluate the long-term safety and pharmacodynamic effects of votoplam in participants with HD.
Описание
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).
Кой може да участва
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.
Места на провеждане 9
Австралия (1)
Novartis Investigative Site
Clayton
Канада (1)
Novartis Investigative Site
Ottawa
Франция (1)
Novartis Investigative Site
Angers
Германия (1)
Novartis Investigative Site
Berlin
Италия (1)
Novartis Investigative Site
Bologna
Нидерландия (1)
Novartis Investigative Site
Leiden
New Zealand (1)
Novartis Investigative Site
Christchurch
Испания (1)
Novartis Investigative Site
Barakaldo
Великобритания (1)
Novartis Investigative Site
Birmingham
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
25 Years
Здрави доброволци
Не
Начална дата
25.08.2023
Крайна дата
16.07.2029
Регистрационен номер
NCT06254482
Източник
anzctr
Запитване за медицински туризъм

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