HIPAA Compliant
ISO 27001 CertifiedActively Recruiting
Led by Hoffmann-La Roche · Updated on 2026-08-06
900
Participants Needed
184
Research Sites
104 weeks
Total Duration
Researchers are evaluating the efficacy, safety, and how the body processes pharmacokinetics prasinezumab compared with a placebo in people with early-stage Parkinsons disease PD who are on stable levodopa monotherapy. This Phase III study aims to understand if prasinezumab can affect the progression of motor symptoms in this population. Participants will receive either prasinezumab or a placebo as an intravenous IV infusion during the double-blind treatment period. After completing this phase, eligible participants may enter an open-label extension where they can receive prasinezumab. Infusions are given according to a schedule detailed in the study protocol. Throughout the study, participants will be regularly assessed using the Movement Disorder Society - Unified Parkinsons Disease Rating Scale MDS-UPDRS Part III to monitor motor progression, along with other clinical measures and safety evaluations. Researchers will also track adverse events, antibody development against the drug, and drug levels in the blood. The study includes monitoring up to at least 104 weeks, with safety follow-up extending 70 days after the final dose.
CONDITIONS
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
R
Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below.
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Hoffmann-La Roche
Lead Sponsor
Prothena Biosciences Limited
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Prasinezumab (IV infusion) | Placebo (IV infusion) |
|---|---|---|
| What it is | Prasinezumab is a humanized monoclonal antibody designed to bind aggregated alpha-synuclein, administered by intravenous infusion according to the study protocol. | Placebo intravenous infusion matches the appearance and schedule of the investigational drug but does not contain active medication. |
| Role in trial | Investigational treatment arm; evaluates whether prasinezumab can slow motor progression in early-stage Parkinson's disease. | Comparator arm; receives placebo to determine the effect of prasinezumab compared with no active intervention. |
| Primary use | Studied as a potential disease-modifying therapy for slowing motor progression in adults with early Parkinson's disease. | Serves as a comparison to measure motor progression in the absence of active drug intervention. |
| How it is given or performed | Administered as an intravenous infusion at specified intervals according to the study protocol. | Given as an intravenous infusion matching the schedule and appearance of prasinezumab. |
| Evidence status | Further phase 3 evaluation is ongoing after completion of a prior multicentre, double-blind, placebo-controlled randomized study (PADOVA). Results are not yet established for this investigational therapy. | Outcomes in the placebo group represent the progression of Parkinson's disease without active disease-modifying intervention. Placebo is used as a standard comparator in disease-modification trials. |
| Important limitations | The long-term benefit and safety of prasinezumab for slowing disease progression are not yet confirmed. Results from ongoing phase 3 investigation are awaited. Past phase 2 studies have not established significant disease-modifying effects. | Placebo does not alter the underlying progression of Parkinson's disease; motor decline is expected to continue without disease-modifying therapy. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 104 weeks
Participants receive either prasinezumab or placebo as an intravenous infusion according to the study schedule.
Regular visits for infusions and assessments
Duration - Duration varies by participant
Eligible participants may receive prasinezumab in an open-label phase following the double-blind period.
Visits as scheduled per protocol
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Tania Nikolcheva, Gennaro Pagano, Judith Anzures-Cabrera...
https://pubmed.ncbi.nlm.nih.gov/42208564/Hoffmann-La Roche
Lead Sponsor
Prothena Biosciences Limited
Collaborating Sponsor
