Език: EN EN
← Назад към резултатите
Набира участници Фаза 3 NCT07174310

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Фаза 3 – широко изпитване преди одобрение
Заболявания: Parkinson's Disease

Спонсор: Hoffmann-La Roche

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
Кой може да участва
Inclusion Criteria: * Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2 * Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria * Has received monotherapy treatment * An MDS-UPDRS Part IV score of 0 at screening and prior to randomization * Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization * Agreement to adhere to the contraception requirements Exclusion Criteria: * Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required * Medical history indicating a parkinsonian syndrome other than idiopathic PD * Diagnosis of a significant neurologic disease other than PD * Chronic uncontrolled hypertension
Места на провеждане 13
Австралия (1)
Southern Neurology
Kogarah , New South Wales
Бразилия (1)
Instituto de Neurologia de Curitiba
Curitiba , Paraná
Канада (1)
CHUM
Montreal , Quebec
Китай (1)
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing
Дания (1)
Aarhus Universitetshospital Skejby
Aarhus N
Италия (1)
Università degli studi della Campania Luigi Vanvitelli
Naples , Campania
Mexico (1)
Hospital General de Mexico
Mexico City , Mexico CITY (federal District)
Полша (1)
Podlaskie Centrum Psychogeriatrii
Bia?ystok
Южна Корея (1)
Severance Hospital, Yonsei University Health System
Seoul
Испания (1)
Hospital General De Catalunya
Sant Cugat del Vallès , Barcelona
Taiwan (1)
Changhua Christian Hospital
Changhua County
Великобритания (1)
Ninewells Hospital, Dundee- Scotland
Dundee
САЩ (1)
Neurology Center of North Orange County
Fullerton , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
50 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
24.11.2025
Крайна дата
30.06.2031
Регистрационен номер
NCT07174310
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.