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A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease

NCT03100149 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2026-03-17

Study results available
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Summary

This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be offered participation in Part 3 open-label extension (all-participants-on-RO7046015-treatment) for an additional 520 weeks.

Conditions

Interventions

DRUG

RO7046015

RO7046015 will be administered at dose of 4500 milligrams (mg) for participants with body-weight greater than or equal to (\>/=) 65 kilograms (kg) or 3500 mg for participants with body-weight less than (\<) 65 kg.

DRUG

RO7046015

RO7046015 will be administered at dose of 1500 mg to all participants in the indicated arm.

DRUG

Placebo

RO7046015 placebo will be administered to all participants in the indicated arm.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2019-11-27
Completion
2031-12-01
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03100149 on ClinicalTrials.gov