Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Prothena Biosciences Limited
Conditions:
Parkinson's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE3
Brief 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 sympt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2031
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT07174310
Start Date
November 24 2025
End Date
June 30 2031
Last Update
December 16 2025
Active Locations (10)
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1
JEM Research LLC
Atlantis, Florida, United States, 33462
2
K2 - Villages
Lady Lake, Florida, United States, 32159
3
K2 Medical Research-Maitland
Maitland, Florida, United States, 32751
4
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States, 96817