A Study to Evaluate the Efficacy of RO7046015 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 (PRX002) in Participants With Early Parkinson's Disease With a 52-Week Blinded Extension (PASADENA)

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 40 - 80 Status: Recruiting
Time Since Diagnosis: Less than 2 years Study Focus: Bradykinesia (slowness of movement), rigidity, Tremors

Study Purpose:

This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous RO7046015 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 2 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).

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More Details

Phase: Phase 2 Lead Sponsor: Hoffmann-La Roche
Trial ID: 004926 Sponsor Type: Industry
Primary Country: United States Additional Collaborators or Sponsors: Prothena Biosciences Limited
Estimated Enrollment: 300 Study Start Date: June 2017
Estimated Study Completion Date: June 2021 Source: ClinicalTrials.gov
Study Website: www.pasadenastudy.com

More Inclusion & Exclusion Criteria

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