NCT03100149

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

A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 11-Year All-Participants-on-Treatment Extension

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Parkinson's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-27
• Primary completion: 2019-11-27
• Completion: 2031-12-01
• First posted: 2017-04-04
• Last updated: 2026-03-17
• Results posted: 2021-02-08

Locations

55 sites across 5 countries: United States, Austria, France, Germany, Spain

Regulatory

• FDA-regulated drug study