A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease

Phase 1

Recruiting

Conditions: Early Parkinson's disease
MedDRA version: 20.0Level: PTClassification code: 10061536Term: Parkinson's disease Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: CTIS2023-507132-21-00

Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 586

Inclusion Criteria

Diagnosis of idiopathic Parkinson's disease (PD) based on Movement disorder society (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, Movement Disorder Society - Unified Parkinson's Disease Rating Scale (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

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of prasinezumab compared with placebo on basis of time to confirmed motor progression event;Secondary Objective: To evaluate the efficacy of prasinezumab compared with placebo on basis of time-to-worsening of patient’s motor function as reported by the patient in the presence of a confirmed motor progression event, time to meaningful worsening in the overall disease as reported by the patient and by the clinician, change from baseline in motor function, change from baseline in bradykinesia and rigidity, time to onset of motor complications, To evaluate the safety of prasinezumab compared with placebo, To characterize the prasinezumab pharmacokinetic (PK) profile, To evaluate the immune response to prasinezumab;Primary end point(s): 1. Time to confirmed motor progression event

Secondary Outcome Measures