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Clinical Trials List

Protocol NumberBN44715
NCT Number(ClinicalTrials.gov Identfier)NCT07174310
Active

2025-10-15 - 2032-12-31

Phase III

Recruiting6

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

    2026/08/20

Investigators and Locations

Principal Investigator 吳逸如

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 莊介森

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 朱永載

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Kuei Lu

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林典佑

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Parkinson's Disease

Objectives

本試驗之目的旨在評估prasinezumab相較於安慰劑,在穩定接受levodopa症狀性單一療法之早期帕金森氏症(PD)患者身上的療效、安全性及藥物動力學。 到目前為止,尚未有針對其潛在病理機制,進而能夠改變疾病進程的治療獲得核准。標準照護包括改善多巴胺訊號傳導異常,進而緩解運動症狀的症狀性治療。但是,對於患者而言,最迫切且未獲滿足的需求,仍然是能夠改變疾病進程的治療。

Test Drug

注射劑

Active Ingredient

prasinezumab

Dosage Form

270

Dosage

1512mg/8.4ml

Endpoints

評估prasinezumab相較於安慰劑的療效(針對穩定接受levodopa症狀性單一療法的參與者,不論其LEDD在試驗期間是否增加,以及是否中止試驗治療

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