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Recruiting Phase 3 NCT07174310

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

Phase 3 – large-scale trial before approval
Conditions: Parkinson's Disease

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 13
Australia (1)
Southern Neurology
Kogarah , New South Wales
Brazil (1)
Instituto de Neurologia de Curitiba
Curitiba , Paraná
Canada (1)
CHUM
Montreal , Quebec
China (1)
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing
Denmark (1)
Aarhus Universitetshospital Skejby
Aarhus N
Italy (1)
Università degli studi della Campania Luigi Vanvitelli
Naples , Campania
Mexico (1)
Hospital General de Mexico
Mexico City , Mexico CITY (federal District)
Poland (1)
Podlaskie Centrum Psychogeriatrii
Bia?ystok
South Korea (1)
Severance Hospital, Yonsei University Health System
Seoul
Spain (1)
Hospital General De Catalunya
Sant Cugat del Vallès , Barcelona
Taiwan (1)
Changhua Christian Hospital
Changhua County
United Kingdom (1)
Ninewells Hospital, Dundee- Scotland
Dundee
United States (1)
Neurology Center of North Orange County
Fullerton , California
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
50 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
24.11.2025
Completion date
30.06.2031
Registry ID
NCT07174310
Source
anzctr
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