4 trials tracked · 4 active · last refreshed 2026-08-10
Prasinezumab (RO7046015) is Roche and Prothena's monoclonal antibody targeting aggregated alpha-synuclein, the misfolded protein that clumps into Lewy bodies in Parkinson's disease — the idea is to clear or block the toxic protein directly, rather than just replacing lost dopamine. It's the furthest-along immunotherapy approach in Parkinson's, now in Phase III after an earlier Phase II trial suggested it may slow motor decline in a specific subgroup of faster-progressing patients.
Its other active trials extend that Phase II follow-up long-term and test it in GBA-associated Parkinson's — a genetically defined subgroup (see Ambroxol, tracked separately, for a different drug targeting the same genetic subgroup) — reflecting a broader shift toward matching Parkinson's treatments to specific biological subtypes rather than treating the disease as one thing.
Click a row for what it's testing, where, and how many participants.
| NCT ID | Title | Phase | Status | Started | |
|---|---|---|---|---|---|
| ▸ | NCT07055087 | Prevent Cognitive Decline in GBA-associated Parkinson's Disease | Phase II | Not yet recruiting | 2025-12 |
This is a proof-of-concept trial to investigate the efficacy of prasinezumab to slow or prevent cognitive decline in people with Parkinson's disease carrying a severe mutation in the GBA (glucocerebrosidase) gene. The duration of the intervention per patient will be 104 weeks with monthly infusions. The investigators plan to enroll 120 participants (60 participants per treatment arm). This study will be conducted across Europe in the following countries: France, Germany, Italy, Luxembourg, Spain, Sweden, UK. Enrollment 120 (estimated) Sites 8 across 7 countries Countries France, Germany, Italy, Luxembourg, Spain +2 more Sponsor University Hospital Tuebingen Primary outcome: Parkinson's Disease Cognitive Composite Score (PDCCS) | |||||
| ▸ | NCT07174310 | A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease | Phase III | Recruiting | 2025-11-24 |
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa. Enrollment 900 (estimated) Sites 184 across 17 countries Countries Australia, Austria, Brazil, Canada, China +12 more Sponsor Hoffmann-La Roche Primary outcome: Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score | |||||
| ▸ | NCT04777331 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease | Phase II | Active, not recruiting | 2021-05-05 |
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. Enrollment 586 (actual) Sites 110 across 9 countries Countries Austria, Canada, France, Italy, Luxembourg +4 more Sponsor Hoffmann-La Roche Primary outcome: DBT Period: Time to Confirmed Motor Progression Event Assessed by Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | |||||
| ▸ | NCT03100149 | A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease | Phase II | Active, not recruiting | 2017-06-27 |
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. Enrollment 316 (actual) Sites 55 across 5 countries Countries Austria, France, Germany, Spain, United States Sponsor Hoffmann-La Roche Primary outcome: Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 | |||||
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