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Набира участници Фаза 3 2025-523481-24-00

A Phase III, randomized, placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy followed by an Open Label Extension

Фаза 3 – широко изпитване преди одобрение
Заболявания: Participants with Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)

Спонсор: Novartis Pharma AG

Налично на: БГ
Обобщение
Trial status: Authorised Change from baseline at Week 72 in the PSPRS-28, Changes from baseline at Week 72 in activities of daily living on the XXX, Change from baseline at Week 72 in the Progressive Supranuclear Palsy Quality of Life scale (PSP-ShoQoL), Change from baseline at Week 72 in the Category Fluency, Phonemic Fluency, Symbol Digit Modality Test (SDMT), and Letter-Number- Sequencing (LNS), Changes from baseline in volumes of ventricles, whole brain, midbrain, pons, superior cerebellar peduncle, third ventricle, frontal lobe as measured by MRI until Week 72., Safety and tolerability parameters including AEs, AESIs, SAEs (including SAEs with fatal outcomes), AEs leading to XXX and treatment interruptions, AEs leading to dose discontinuation, clinical laboratory evaluations, vital signs, electrocardiogram (ECG), XXX Change from baseline at Week 72 in the rPSPRS-10 score
Описание
Change from baseline at Week 72 in the PSPRS-28, Changes from baseline at Week 72 in activities of daily living on the XXX, Change from baseline at Week 72 in the Progressive Supranuclear Palsy Quality of Life scale (PSP-ShoQoL), Change from baseline at Week 72 in the Category Fluency, Phonemic Fluency, Symbol Digit Modality Test (SDMT), and Letter-Number- Sequencing (LNS), Changes from baseline in volumes of ventricles, whole brain, midbrain, pons, superior cerebellar peduncle, third ventricle, frontal lobe as measured by MRI until Week 72., Safety and tolerability parameters including AEs, AESIs, SAEs (including SAEs with fatal outcomes), AEs leading to XXX and treatment interruptions, AEs leading to dose discontinuation, clinical laboratory evaluations, vital signs, electrocardiogram (ECG), XXX
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 56 participants
Интервенции
NIO752
Drug
Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung
Drug
Места на провеждане 3
Белгия (1)
Германия (1)
Нидерландия (1)
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
21.04.2026
Регистрационен номер
2025-523481-24-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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