A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Prasinezumab: Prasinezumab will be administered as an IV infusion to participants Q4W.
Placebo: Prasinezumab placebo will be administered to participants.
Study summary
This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.
Eligibility
Primary outcome measure(s)
- DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III — From study start to end of DBT period to at least 76 weeks
Time to confirmed motor progression event was the first time point of a worsening event defined as either \>= 5 points increase in MDS-UPDRS Part III score (assessed in "OFF" medication state) from baseline sustained over 2 consecutive assessments or a change in medication after first occurrence of \>= 5 points increase in MDS-UPDRS Part III score from baseline \& before follow-up assessment. MDS-UPDRS Part III is a clinician rater scale that assessed the motor signs of PD. The scale is composed of 18 clinical domains or tasks, which yield 33 distinct scores or ratings. For each distinct rating, a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, and 4 = Severe. The total MDS-UPDRS Part III score (ranging from 0 to 132) is calculated by summing these 33 individual ratings, with higher scores indicating severe impairment.
Trial sites (110)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Barrow Neurological Institute | Phoenix | Arizona | |
| Neurology Center of North Orange County | Fullerton | California | |
| UC San Diego | La Jolla | California | |
| Keck School of Medicine of USC | Los Angeles | California | |
| Cedars Sinai Medical Center | Los Angeles | California | |
| University of California San Francisco | San Francisco | California | |
| CenExel Rocky Mountain Clinical Research, LLC | Englewood | Colorado | |
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | |
| JEM Research LLC | Atlantis | Florida | |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | |
| Renstar Medical Research | Ocala | Florida | |
| University of South Florida | Tampa | Florida | |
| Charter Research - Winter Park/Orlando | Winter Park | Florida | |
| Northwestern University Feinberg School Of Medicine | Chicago | Illinois | |
| Southern Illinois University, School of Medicine | Springfield | Illinois | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Quest Research Institute | Farmington Hills | Michigan | |
| Henry Ford Hospital | West Bloomfield | Michigan | |
| Dent Neurological Institute | Amherst | New York | |
| Cleveland Clinic | Cleveland | Ohio | |
| The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma | |
| University Pennsylvania Hospital | Philadelphia | Pennsylvania | |
| Texas Neurology PA | Dallas | Texas | |
| Baylor College of Medicine Medical Center | Houston | Texas | |
| Central Texas Neurology Consultants | Round Rock | Texas | |
| University of Vermont Medical Center | Burlington | Vermont | |
| Sentara Neurology Specialists | Norfolk | Virginia | |
| EvergreenHealth Investigational Drug Services | Kirkland | Washington | |
| Inland Northwest Research | Spokane | Washington | |
| Medizinische Universität Graz | Graz | Austria | |
| Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck | Innsbruck | Austria | |
| Klinik Ottakring | Vienna | Austria | |
| Toronto Memory Program | Toronto | Ontario | |
| Toronto Western Hospital | Toronto | Ontario | |
| Clinique Neuro Outaouais | Gatineau | Quebec | |
| Montreal Neurological Institute and Hospital | Montreal | Quebec | |
| Groupe Hospitalier Pellegrin | Bordeaux | France | |
| Groupement Hospitalier Est - Hôpital Neurologique | Bron | France |
+ 70 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04777331 on ClinicalTrials.gov ↗ ← All trials in Poland