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