Идёт набор NCT07174310

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

Фаза III С лечением Parkinson's Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Prasinezumab, Placebo.
Кому может быть актуально: Состояния в реестре: Parkinson's Disease. Базовые параметры: 50 лет — 85 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия, Австрия, Бразилия, Канада +12
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early-Stage Parkinson's Disease

Обзор

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.

Вмешательства

Препарат Prasinezumab
Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
Препарат Placebo
Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol

Первичные конечные точки

Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score [Срок оценки: Up to at least Week 104]

Вторичные конечные точки (11)

Change From Baseline in Motor Function as Measured by the MDS-UPDRS Part III off Medication Score [Срок оценки: Baseline, Week 104]
Time to Worsening of Participants Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event [Срок оценки: Up to at least Week 104]
Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C), Overall Disease Subscale [Срок оценки: Up to at least Week 104]
Time to increase in Levodopa Equivalent Daily Dose (LEDD) [Срок оценки: Up to at least Week 104]
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: From Baseline up to 70 days after the final study dose (up to at least Week 104)]
Percentage of Participants With Adverse Events of Special Interest (AESI) [Срок оценки: From Baseline up to 70 days after the final study dose (up to at least Week 104)]
Percentage of Participants With Infusion Related Reactions (IRRs) [Срок оценки: From Baseline up to 70 days after the final study dose (up to at least Week 104)]
Percentage of Participants With Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: From Baseline up to 70 days after the final study dose (up to at least Week 104)]
Serum Concentration of Prasinezumab [Срок оценки: Predose and postdose at Baseline, Week 1, 4, 12, 24, 36, 52, 76, and after week 76 every 12 weeks thereafter until end of study (up to at least Week 104)]
Percentage of Participants With Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline [Срок оценки: At Baseline]
Percentage of Participants With ADAs Against Prasinezumab During the Study [Срок оценки: From Baseline up to 70 days after the final study dose (up to at least Week 104)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Тройное слепое
Основная цель: Лечение

Центры проведения

США · 50 центров

University of Alabama at Birmingham — Birmingham
Barrow Neurological Institute — Phoenix
Neurology Center of North Orange County — Fullerton
UC San Diego — La Jolla
Keck School of Medicine of USC — Los Angeles
UCLA Neurology Outpatient Clinic — Los Angeles
Parkinson?s Research Centers of America ? Palo Alto — Palo Alto
Profound Research LLC at The Neurology Center of Southern California — Pasadena
… и ещё 42 центра

Китай · 21 центр

Beijing Friendship Hospital Affiliated of Capital University of Medical Science — Пекин
Xuanwu Hospital, Capital Medical University — Пекин
Beijing Tian Tan Hospital,Capital Medical University — Пекин
Beijing Hospital of Ministry of Health — Пекин
The First Hospital of Jilin University — Changchun
West China Hospital of Sichuan University — Чэнду
The First Affiliated Hospital, Chongqing Medical University — Чунцин
Fujian Medical University Union Hospital — Фучжоу
… и ещё 13 центров

Германия · 16 центров