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

Roche

Status and phase: Enrolling; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Prasinezumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07174310

BN44715

2025-522683-32-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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900 participants in 2 patient groups

Prasinezumab

Experimental group

Description:

Participants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase.

Treatment:

Drug: Prasinezumab

Placebo

Experimental group

Description:

Participants will receive placebo as an IV Infusion.

Treatment:

Drug: Placebo