Summary

Eligibility
for people ages 50-85 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

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

Keywords

Parkinsons Disease Parkinson Disease Prasinezumab

Eligibility

You can join if…

Open to people ages 50-85

  • 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 for at least 6 months, with stable doses for 3 months prior to baseline
  • A diagnosis of PD for at least 6 months to maximum 3 years at screening
  • MDS-UPDRS Part IV score= 0
  • Hoehn and Yahr (H&Y) Stage I or II in ON and OFF states
  • 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

You CAN'T join if...

  • Medical history indicating a Parkinsonian syndrome other than idiopathic PD
  • Diagnosis of PD dementia
  • Diagnosis of a significant central nervous system (CNS) disease other than Parkinson's disease
  • 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

Locations

  • UC San Diego not yet accepting patients
    La Jolla California 92037 United States
  • Collaborative Neuroscience Network, Inc. not yet accepting patients
    Garden Grove California 92845 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04777331
Phase
Phase 2
Study Type
Interventional
Last Updated