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A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

RECRUITINGPhase 3Sponsored by Hoffmann-La Roche
Actively Recruiting
PhasePhase 3
SponsorHoffmann-La Roche
Started2025-11-24
Est. completion2029-06-30
Eligibility
Age50 Years – 85 Years
Healthy vol.Accepted
Locations19 sites
View on ClinicalTrials.gov →

NCT07174310

Summary

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.

Eligibility

Age: 50 Years – 85 YearsHealthy volunteers accepted
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

Conditions1

Parkinson's Disease

Locations19 sites

Neurology Center of North Orange County
Fullerton, California, 92835
Keck School of Medicine of USC
Los Angeles, California, 900033
Profound Research LLC at The Neurology Center of Southern California
Pasadena, California, 91105
UCSF Weill Institute for Neurosciences
San Francisco, California, 94158
Rocky Mountain Movement Disorders
Englewood, Colorado, 80113

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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