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ACTIVE NOT RECRUITING Phase 2

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

NCT03100149 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Placebo
  • DRUG RO7046015

Study Locations (20)

California

  • Neurology Center of North Orange County — Fullerton
  • USC Keck Medical Center of USC — Los Angeles
  • University of California at San Francisco — San Francisco

Florida

  • Aventura Neurologic Associates — Aventura
  • Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton
  • USF Parkinsons Disease and Movement Disorders Center — Tampa

Michigan

  • Quest Research Institute — Farmington Hills
  • Corewell Health Neurology and Epilepsy - Beltline — Grand Rapids
  • Henry Ford Health System — West Bloomfield

Connecticut

  • Associated Neurologists of Southern CT PC — Fairfield
  • Molecular Neurolmaging — New Haven

New York

  • Columbia University — New York
  • University of Rochester Medical Center — Rochester

Alabama

  • Uab Medicine — Birmingham

Arizona

  • Barrow Neurology Clinics — Phoenix

Colorado

  • CenExel Rocky Mountain Clinical Research, LLC — Englewood

Trial Details

FieldValue
Enrollment Target 316 participants
Start Date 2017-06-27
Est. Completion 2031-12-01
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03100149

The ClinicalTrials.gov registry entry for NCT03100149 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03100149 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03100149 about?

NCT03100149 is a clinical study titled "A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease". 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) inhib...

What is the current status of trial NCT03100149?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 316 participants. The study started on 2017-06-27. Estimated completion is 2031-12-01.

What conditions does trial NCT03100149 study?

This clinical trial studies the following conditions: Parkinson's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03100149?

The interventions under investigation include: Placebo (DRUG), RO7046015 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03100149?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03100149 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial