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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
900
Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol
Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
Time frame: Up to at least Week 104
Change From Baseline in Motor Function as Measured by the MDS-UPDRS Part III off Medication Score
Time frame: Baseline, Week 104
Time to Worsening of Participants Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event
Time frame: Up to at least Week 104
Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C), Overall Disease Subscale
Time frame: Up to at least Week 104
Time to increase in Levodopa Equivalent Daily Dose (LEDD)
Time frame: Up to at least Week 104
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From Baseline up to 70 days after the final study dose (up to at least Week 104)
Percentage of Participants With Adverse Events of Special Interest (AESI)
Time frame: From Baseline up to 70 days after the final study dose (up to at least Week 104)
Percentage of Participants With Infusion Related Reactions (IRRs)
Time frame: From Baseline up to 70 days after the final study dose (up to at least Week 104)
Percentage of Participants With Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGBarrow Neurological Institute
Phoenix, Arizona, United States
RECRUITINGNeurology Center of North Orange County
Fullerton, California, United States
RECRUITINGUC San Diego
La Jolla, California, United States
RECRUITINGKeck School of Medicine of USC
Los Angeles, California, United States
RECRUITINGUCLA Neurology Outpatient Clinic
Los Angeles, California, United States
RECRUITINGParkinson?s Research Centers of America ? Palo Alto
Palo Alto, California, United States
RECRUITINGProfound Research LLC at The Neurology Center of Southern California
Pasadena, California, United States
RECRUITINGUCSF Weill Institute for Neurosciences
San Francisco, California, United States
RECRUITINGStanford Neuroscience Health Center (SNHC)
Stanford, California, United States
RECRUITING...and 182 more locations
Time frame: From Baseline up to 70 days after the final study dose (up to at least Week 104)
Serum Concentration of Prasinezumab
Time frame: Predose and postdose at Baseline, Week 1, 4, 12, 24, 36, 52, 76, and after week 76 every 12 weeks thereafter until end of study (up to at least Week 104)
Percentage of Participants With Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline
Time frame: At Baseline
Percentage of Participants With ADAs Against Prasinezumab During the Study
Time frame: From Baseline up to 70 days after the final study dose (up to at least Week 104)