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IV prasinezumab treatment for people with early-stage Parkinson's disease

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early-Stage Parkinson's Disease

Phase 3 Interventional Hoffmann-La Roche · NCT07174310

This study will try IV prasinezumab versus placebo in people with early-stage Parkinson's disease who are on stable levodopa monotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment900 (estimated)
Ages50 Years to 85 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsprasinezumab
Locations142 sites (Birmingham, Alabama and 141 other locations)
Trial IDNCT07174310 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, placebo-controlled trial testing intravenous prasinezumab compared with placebo in participants with early-stage idiopathic Parkinson's disease. Adults must be on stable symptomatic monotherapy with levodopa, meet Hoehn and Yahr stage 1–2 off medication, and have an MDS-UPDRS Part IV score of 0 at screening. The study will collect efficacy, safety, and pharmacokinetic (PK) data over the treatment and follow-up periods. Key exclusions include non-idiopathic parkinsonian syndromes, other significant neurologic diseases, pregnancy/breastfeeding, and uncontrolled chronic hypertension.

Who should consider this trial

Good fit: Ideal candidates are adults with idiopathic early-stage Parkinson's disease (Hoehn and Yahr stage 1–2) on stable levodopa monotherapy who meet the study's weight/BMI and screening score requirements.

Not a fit: People who are pregnant or breastfeeding, have non-idiopathic parkinsonism or other significant neurological disease, or have uncontrolled chronic hypertension are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, prasinezumab could slow disease progression in early Parkinson's and improve longer-term clinical outcomes.

How similar studies have performed: Earlier clinical programs of prasinezumab and other anti–alpha-synuclein antibodies have been conducted with mixed or inconclusive results, so this Phase 3 trial is testing the approach at larger scale.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2
* Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
* Has received monotherapy treatment
* An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
* Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization
* Agreement to adhere to the contraception requirements

Exclusion Criteria:

* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
* Medical history indicating a parkinsonian syndrome other than idiopathic PD
* Diagnosis of a significant neurologic disease other than PD
* Chronic uncontrolled hypertension

Where this trial is running

Birmingham, Alabama and 141 other locations

+92 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Parkinson's Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.