Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism - On symptomatic PD medication, with stable doses for at least 3 months prior to baseline - A diagnosis of PD for at least 3 months to maximum 3 years at screening - MDS-UPDRS Part IV score of 0 at screening and prior to randomization - Hoehn and Yahr (H&Y) Stage I or II in OFF medication state at screening and prior to randomization - Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader - No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening - Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study - Willingness and ability to wear a smartwatch to measure PD-related motor signs

Exclusion Criteria

  • Medical history indicating a Parkinsonian syndrome other than idiopathic PD - Diagnosis of PD dementia - Diagnosis of a significant neurologic disease other than PD - Within the last year, unstable or clinically significant cardiovascular disease - Uncontrolled hypertension - Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed) - Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis - Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody - Any contraindications to obtaining a brain magnetic resonance imaging (MRI) - Any contraindications to DaT-SPECT imaging

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Prasinezumab
Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.
  • Drug: Prasinezumab
    Prasinezumab will be administered as an IV infusion to participants Q4W.
Placebo Comparator
Placebo
Participants will receive placebo as an IV infusion Q4W.
  • Drug: Placebo
    Prasinezumab placebo will be administered to participants.

More Details

Status
Active, not recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.