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ONO-2808 在多系统萎缩患者中的 2 期研究

2026年9月14日 更新者：Ono Pharmaceutical Co., Ltd.

一项双盲、安慰剂对照、平行组研究，旨在评估多剂量 ONO-2808 对多系统萎缩 (MSA) 患者的安全性、耐受性、药代动力学、药效学和潜在疗效

This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of ONO-2808 in patients with MSA. This is the first study of ONO-2808 in patients with MSA.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

This study will consist of a core part, an extension part, and an additional extension part. The purpose of the core part is to evaluate 3 doses of ONO-2808 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) changes in clinical outcome assessments (COA) and biomarkers considered to be related to the pharmacodynamics and potential efficacy of ONO-2808. The purpose of the extension part and the additional extension part is to evaluate 3 doses of ONO-2808 in MSA patients, including: 1) safety and tolerability and 2) changes in COAs and biomarkers considered to be related to the pharmacodynamics and potential efficacy of ONO-2808.

研究类型

介入性

注册 (实际的)

92

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 日本
    • Aichi-ken
      • Toyoake、Aichi-ken、日本
        • Fujita Health University Hospital
    • Kyoto
      • Kyoto、Kyoto、日本
        • National Hospital Organization Utano National Hospital
    • Miyagi
      • Sendai、Miyagi、日本
        • National Hospital Organization Sendai Nishitaga Hospital
    • Osaka
      • Toyonaka、Osaka、日本
        • National Hospital Organization Osaka Toneyama Medical Center
    • Tokyo
      • Fuchū、Tokyo、日本
        • Tokyo Metropolitan Neurological Hospital
  • 美国
    • California
      • Fountain Valley、California、美国、92708
        • The Parkinson's Movement and Disorder Institute
      • Los Angeles、California、美国、90033
        • University of Southern California
      • Los Angeles、California、美国、90095
        • David Geffen School of Medicine at UCLA
      • Palo Alto、California、美国、94304
        • Stanford University School of Medicine
    • Colorado
      • Englewood、Colorado、美国、80113
        • CenExel Rocky Mountain Clinical Research
    • Connecticut
      • New Haven、Connecticut、美国、06519
        • Yale School of Medicine - Yale Church Street Research Unit (CRSU)
    • Florida
      • Boca Raton、Florida、美国、33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
      • Gainesville、Florida、美国、32608
        • Norman Fixel Institute for Neurological Diseases - University of Florida
      • Jacksonville、Florida、美国、32224
        • Mayo Clinic in Florida
      • Miami、Florida、美国、33136
        • University of Miami Miller School of Medicine
    • Georgia
      • Atlanta、Georgia、美国、30329
        • Emory University School of Medicine
    • Kansas
      • Kansas City、Kansas、美国、66160
        • University of Kansas Medical Center Research Institute
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan School of Medicine
      • Farmington Hills、Michigan、美国、48334
        • Quest Research Institute
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic - Rochester
    • Nebraska
      • Omaha、Nebraska、美国、68198
        • University of Nebraska Medical Center
    • New York
      • New York、New York、美国、10032
        • Columbia University
      • New York、New York、美国、10019
        • Icahn School of Medicine at Mount Sinai
      • New York、New York、美国、10016
        • NYU Langone Health - NYU Dysautonomia Center
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • University of Cincinnati College of Medicine
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic
      • Columbus、Ohio、美国、43201
        • Ohio State University
    • Pennsylvania
      • Hershey、Pennsylvania、美国、17033
        • Penn State University - Milton S. Hershey Medical Center
      • Philadelphia、Pennsylvania、美国、19107
        • The University of Pennsylvania - Pennsylvania Hospital
    • Texas
      • Dallas、Texas、美国、75390
        • UT Southwestern Medical Center
    • Virginia
      • Richmond、Virginia、美国、23298
        • Virginia Commonwealth University Medical Center
    • Washington
      • Kirkland、Washington、美国、98034
        • Evergreen Health
      • Seattle、Washington、美国、98122
        • Swedish Neuroscience Institute, Movement Disorders Clinic

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Female or male patients with a diagnosis of clinically-established or clinically-probable MSA according to the novel Movement Disorder Society (MDS) criteria for MSA diagnosis (2022), including patients with MSA of either subtype (MSA-P or MSA-C).

  2. Patients at the early stages of the disease, defined as a maximum of 5 years since the onset of one of the following symptoms associated with MSA:

    • Parkinsonism
    • Ataxia
    • Orthostatic hypotension and/or urinary dysfunction

  3. Patients with an anticipated survival of at least 3 years in the opinion of the Investigator.

  4. Patients who are able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps and then to turn around and walk at least another 10 steps. Use of assistive devices (e.g., walker or cane) is allowed.

  5. Ability to swallow oral medication and be willing to adhere to the study intervention regimen.

Exclusion Criteria:

  1. Pregnant or lactating females.
  2. Patients with a clinically-significant or unstable medical or surgical condition other than MSA that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (e.g., pulmonary, cardiovascular [including bradyarrhythmia], macular edema, and significant renal or hepatic dysfunction).
  3. Neurological diseases/disorders other than MSA, such as Parkinson's disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, normal pressure hydrocephalus, pharmacological, or post-encephalitic parkinsonism.
  4. Patients with documented liver diseases or cirrhosis.
  5. Positive results at Screening for active viral infections that include positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis B core antibody, and hepatitis C virus (HCV).
  6. Patients with suicide ideation according to the Investigator's clinical judgment per the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening or who have made a suicide attempt in the 6 months before Screening.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂组
药品：Placebo

Oral administration of placebo once daily for 24 weeks in the core part and for a total of 32 weeks including the extension part; Transition to low-dose of ONO-2808 for remainder of the extension part until week 80 and for up to an additional 72 weeks in the additional extension part
实验性的：ONO-2808 手臂
药品：ONO-2808

Oral administration of ONO-2808 at low, middle or high doses once daily for 24 weeks in the core part, for a total of 80 weeks including the extension part, and for up to an additional 72 weeks in the additional extension part

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
大体时间：From screening up to follow-up for the core part (up to Week 28)

A TEAE was defined as any adverse event occurring or worsening on or after the first dose of study treatment. A TEAE was considered study treatment-related if there was a reasonable causal relationship between study intervention administration and the TEAE. A serious adverse event (SAE) was an event that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in significant disability/incapacity, was a congenital anomaly/birth defect, or was considered an important medical event.
From screening up to follow-up for the core part (up to Week 28)
Incidence of TEAEs by Highest Severity
大体时间：From screening up to follow-up for the core part (up to Week 28)

A TEAE was defined as any adverse event occurring or worsening on or after the first dose of study treatment.
From screening up to follow-up for the core part (up to Week 28)
Incidence of Study Treatment-related TEAEs by Highest Severity
大体时间：From screening up to follow-up for the core part (up to Week 28)

A TEAE was defined as any adverse event occurring or worsening on or after the first dose of study treatment. A TEAE was considered study treatment-related if there was a reasonable causal relationship between study intervention administration and the TEAE.
From screening up to follow-up for the core part (up to Week 28)

次要结果测量

结果测量
措施说明
大体时间
Plasma Concentration of ONO-2808
大体时间：Week 2, Week 8, Week 12, and Week 24

Descriptive summary statistics were calculated for ONO-2808 plasma concentrations, by dose level and time point.
Week 2, Week 8, Week 12, and Week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ono Pharmaceutical Co., Ltd.

调查人员

  • 研究主任：Project Leader、Ono Pharmaceutical Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年9月22日

初级完成 (实际的)

2025年9月15日

研究完成 (估计的)

2027年10月31日

研究注册日期

首次提交

2023年6月7日

首先提交符合 QC 标准的

2023年6月20日

首次发布 (实际的)

2023年6月28日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ONO-2808-03
  • jRCT2041230153 (注册表标识符：Japan Registry of Clinical Trials)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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