Исследование фазы 2 ONO-2808 у пациентов с множественной системной атрофией
Фаза 2, двойное слепое, плацебо-контролируемое, исследование в параллельных группах для оценки безопасности, переносимости, фармакокинетики, фармакодинамики и потенциальной эффективности многократных доз ONO-2808 у пациентов с множественной системной атрофией (MSA)
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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California
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Fountain Valley, California, Соединенные Штаты, 92708
- The Parkinson's Movement and Disorder Institute
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Los Angeles, California, Соединенные Штаты, 90033
- University of Southern California
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Los Angeles, California, Соединенные Штаты, 90095
- David Geffen School of Medicine at UCLA
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Palo Alto, California, Соединенные Штаты, 94304
- Stanford University School of Medicine
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Colorado
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Englewood, Colorado, Соединенные Штаты, 80113
- CenExel Rocky Mountain Clinical Research
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Connecticut
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New Haven, Connecticut, Соединенные Штаты, 06519
- Yale School of Medicine - Yale Church Street Research Unit (CRSU)
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Florida
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Boca Raton, Florida, Соединенные Штаты, 33486
- Parkinson's Disease and Movement Disorders Center of Boca Raton
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Gainesville, Florida, Соединенные Штаты, 32608
- Norman Fixel Institute for Neurological Diseases - University of Florida
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Jacksonville, Florida, Соединенные Штаты, 32224
- Mayo Clinic in Florida
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Miami, Florida, Соединенные Штаты, 33136
- University of Miami Miller School of Medicine
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30329
- Emory University School of Medicine
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Kansas
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Kansas City, Kansas, Соединенные Штаты, 66160
- University of Kansas Medical Center Research Institute
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Соединенные Штаты, 02114
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48109
- University of Michigan School of Medicine
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Farmington Hills, Michigan, Соединенные Штаты, 48334
- Quest Research Institute
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Minnesota
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Rochester, Minnesota, Соединенные Штаты, 55905
- Mayo Clinic - Rochester
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Nebraska
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Omaha, Nebraska, Соединенные Штаты, 68198
- University of Nebraska Medical Center
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New York
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New York, New York, Соединенные Штаты, 10032
- Columbia University
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New York, New York, Соединенные Штаты, 10019
- Icahn School of Medicine at Mount Sinai
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New York, New York, Соединенные Штаты, 10016
- NYU Langone Health - NYU Dysautonomia Center
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45219
- University of Cincinnati College of Medicine
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Cleveland, Ohio, Соединенные Штаты, 44195
- Cleveland Clinic
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Columbus, Ohio, Соединенные Штаты, 43201
- Ohio State University
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Pennsylvania
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Hershey, Pennsylvania, Соединенные Штаты, 17033
- Penn State University - Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Соединенные Штаты, 19107
- The University of Pennsylvania - Pennsylvania Hospital
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Texas
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Dallas, Texas, Соединенные Штаты, 75390
- UT Southwestern Medical Center
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Virginia
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Richmond, Virginia, Соединенные Штаты, 23298
- Virginia Commonwealth University Medical Center
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Washington
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Kirkland, Washington, Соединенные Штаты, 98034
- Evergreen Health
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Seattle, Washington, Соединенные Штаты, 98122
- Swedish Neuroscience Institute, Movement Disorders Clinic
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Aichi-ken
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Toyoake, Aichi-ken, Япония
- Fujita Health University Hospital
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Kyoto
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Kyoto, Kyoto, Япония
- National Hospital Organization Utano National Hospital
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Miyagi
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Sendai, Miyagi, Япония
- National Hospital Organization Sendai Nishitaga Hospital
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Osaka
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Toyonaka, Osaka, Япония
- National Hospital Organization Osaka Toneyama Medical Center
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Tokyo
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Fuchū, Tokyo, Япония
- Tokyo Metropolitan Neurological Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
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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).
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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
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Patients with an anticipated survival of at least 3 years in the opinion of the Investigator.
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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.
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Ability to swallow oral medication and be willing to adhere to the study intervention regimen.
Exclusion Criteria:
- Pregnant or lactating females.
- 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).
- 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.
- Patients with documented liver diseases or cirrhosis.
- 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).
- 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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Плацебо Компаратор: Плацебо Рука
|
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 |
|
Экспериментальный: ОНО-2808 Рука
|
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 |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Временное ограничение: 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)
|
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Incidence of TEAEs by Highest Severity
Временное ограничение: 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)
|
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Incidence of Study Treatment-related TEAEs by Highest Severity
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Plasma Concentration of ONO-2808
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Project Leader, Ono Pharmaceutical Co., Ltd.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ONO-2808-03
- jRCT2041230153 (Идентификатор реестра: Japan Registry of Clinical Trials)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .