NCT07825402尚未招募3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ONO-2808 in Participants With the Parkinsonian Subtype of Multiple System Atrophy (MSA-P)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 486
- 主要终点
- Change from Baseline in modified United Multiple System Atrophy Rating Scale (mUMSARS) Part I (excluding Item 11) with Collapsed Scoring (0-3)
研究概览
简要总结
The main goal of this clinical trial is to learn if ONO-2808 works to treat adults with the Parkinsonian subtype of Multiple System Atrophy (MSA-P). Researchers will compare ONO-2808 to a placebo (a look-alike substance that contains no drug) to see if ONO-2808 works to treat MSA-P.
Participants will:
- Take ONO-2808 or placebo orally for up to 48 weeks
- Make visits to the clinic for checkups and tests
- Answer questions about their health throughout the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a diagnosis of clinically established or clinically probable MSA-P according to the 2022 Movement Disorder Society (MDS) criteria for MSA diagnosis.
- •Participants in 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-P:
- •Parkinsonism
- •Orthostatic hypotension
- •Urinary dysautonomia
- •Participants with an anticipated survival of at least 3 years in the opinion of the Investigator.
- •Participants 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 (eg, walker or cane) is allowed.
- •Ability to swallow oral medication and willingness to adhere to the study drug regimen.
- •Normal range of laboratory values at screening and baseline, especially liver function tests.
- •Participants receiving treatment (including chronic medications, and herbal or dietary supplements) for symptoms associated with MSA must be on a stable dosage for at least 60 days prior to randomization based on the judgment of the Investigator. Participants must not initiate new treatment within 60 days prior to randomization.
排除标准
- •Participants with the cerebellar subtype of MSA according to the 2022 MDS criteria for MSA diagnosis.
- •Female participants who are pregnant, planning to become pregnant during the study, or breastfeeding.
- •Participants with a clinically significant or unstable medical or surgical condition other than MSA-P that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (eg, pulmonary, cardiovascular [including bradyarrhythmia], macular edema, and significant renal or hepatic dysfunction).
- •Neurological diseases/disorders other than MSA-P, 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 postencephalitic parkinsonism.
- •Any abnormalities, other than MSA, found on the centrally read brain MRI that, in the opinion of the Investigator, may constitute a confounder for the study or preclude safe participation.
- •Participants with documented liver diseases, cirrhosis, prior drug-induced liver injury (DILI), or ascites or symptoms and signs of encephalopathy due to hepatic dysfunction.
- •Other protocol-defined inclusion and exclusion criteria apply.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
ONO-2808 High Dose
Experimental
干预措施: ONO-2808 (Drug)
ONO-2808 Low Dose
Experimental
干预措施: ONO-2808 (Drug)
结局指标
主要结局
Change from Baseline in modified United Multiple System Atrophy Rating Scale (mUMSARS) Part I (excluding Item 11) with Collapsed Scoring (0-3)
时间窗: Baseline, Week 48
次要结局
- Change from Baseline in Multiple System Atrophy Quality of Life Scale (MSA-QoL) Motor Subscale Score(Baseline, Week 48)
- Change from Baseline in Magnetic Resonance Imaging (MRI) Volumetric Assessments(Baseline, Week 48)
- Change from Baseline in Total United Multiple System Atrophy Rating Scale (UMSARS) Score (Part I and Part II, all items)(Baseline, Week 48)
- Change from Baseline in mUMSARS Score(Baseline, Week 48)
- Change from Baseline in MSA-QoL Total Score(Baseline, Week 48)
- Change from Baseline in Patient Global Impression of Change (PGI-C) Score(Baseline, Week 48)
- Change from Baseline in Patient Global Impression of Severity (PGI-S) Score(Baseline, Week 48)
- Change from Baseline in Clinical Global Impression of Change (CGI-C) Score(Baseline, Week 48)
- Change from Baseline in Clinical Global Impression of Severity (CGI-S) Score(Baseline, Week 48)
研究者
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