Recruiting NCT07174310

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

Phase III Interventional Parkinson's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Prasinezumab, Placebo.
Who it may be relevant to: Registry conditions: Parkinson's Disease. Basic parameters: 50 years — 85 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Brazil, Canada +12
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

Drug Prasinezumab
Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
Drug Placebo
Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol

Primary outcome measures

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]

Secondary outcome measures (11)

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) [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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Triple blind
Primary purpose: Treatment

Study locations

United States · 50 centers

University of Alabama at Birmingham — Birmingham
Barrow Neurological Institute — Phoenix
Neurology Center of North Orange County — Fullerton
UC San Diego — La Jolla
Keck School of Medicine of USC — Los Angeles
UCLA Neurology Outpatient Clinic — Los Angeles
Parkinson?s Research Centers of America ? Palo Alto — Palo Alto
Profound Research LLC at The Neurology Center of Southern California — Pasadena
… and 42 more centers

China · 21 centers

Beijing Friendship Hospital Affiliated of Capital University of Medical Science — Beijing
Xuanwu Hospital, Capital Medical University — Beijing
Beijing Tian Tan Hospital,Capital Medical University — Beijing
Beijing Hospital of Ministry of Health — Beijing
The First Hospital of Jilin University — Changchun
West China Hospital of Sichuan University — Chengdu
The First Affiliated Hospital, Chongqing Medical University — Chongqing
Fujian Medical University Union Hospital — Fuzhou
… and 13 more centers

Germany · 16 centers