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Clinical Trials List

Protocol NumberBN44715

NCT Number(ClinicalTrials.gov Identfier)NCT07174310

Not yet recruiting

2025-10-15 - 2032-12-31

Phase III

Recruiting5

ICD-10G20

Parkinson's disease

ICD-10G21.4

Vascular parkinsonism

ICD-9332.0

Paralysis agitans

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

Trial Applicant
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 吳逸如無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 莊介森無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ruey-Meei Wu 無

National Taiwan University Hospital

Co-Principal Investigator

CHUN-HWEI TAI 無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Kuei Lu 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林典佑

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Parkinson's Disease

Objectives

The aim of this trial was to evaluate the efficacy, safety, and pharmacokinetics of prasinezumab compared to placebo in patients with early-stage Parkinson's disease (PD) who were stably receiving levodopa as symptomatic monotherapy. To date, no treatment targeting the underlying pathological mechanisms and thus capable of altering disease course has been approved. Standard care includes symptomatic treatment to improve dopamine signaling abnormalities and thereby alleviate motor symptoms. However, the most pressing and unmet need for patients remains a treatment that can alter disease course.

Test Drug

injections

Active Ingredient

prasinezumab

Dosage Form

270

Dosage

1512mg/8.4ml

Endpoints

Evaluate the efficacy of prasinezumab compared to placebo in participants who were stably receiving levodopa symptomatic monotherapy, regardless of whether their LEDD increased during the trial or whether they discontinued trial treatment.

Inclution 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

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

The Estimated Number of Participants

Taiwan

60 participants
Global

900 participants