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A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
900 patients around the world
Available in
United States, Brazil
Hoffmann-La Roche
1
Research sites
900
Patients around the world
This study is for people with
Extrapyramidal and movement disorders
Parkinson's disease
Requirements for the patient
To 85 Years
All Gender
Medical requirements
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.
Sites
CPClin – Centro de Pesquisas Clinicas LTDA
Recruiting
Consult
View site
Avenida Angélica, 2162 – Consolação – São Paulo, SP, CEP:01228-200
View site
Consult
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Study
PARAISO
Sponsor
Hoffmann-La Roche
Study type
Interventional
Conditions
Parkinson's disease
Requirements
To 85 Years
All Gender
Unique study ID
clinicaltrials.gov
NCT07174310
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