다계통 위축 환자를 대상으로 한 ONO-2808의 2상 연구
다계통 위축증(MSA) 환자에서 ONO-2808의 다중 투여의 안전성, 내약성, 약동학, 약력학 및 잠재적 효능을 평가하기 위한 2상, 이중 맹검, 위약 대조, 병렬 그룹 연구
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
California
-
Fountain Valley, California, 미국, 92708
- The Parkinson's Movement and Disorder Institute
-
Los Angeles, California, 미국, 90033
- University of Southern California
-
Los Angeles, California, 미국, 90095
- David Geffen School of Medicine at UCLA
-
Palo Alto, California, 미국, 94304
- Stanford University School of Medicine
-
-
Colorado
-
Englewood, Colorado, 미국, 80113
- CenExel Rocky Mountain Clinical Research
-
-
Connecticut
-
New Haven, Connecticut, 미국, 06519
- Yale School of Medicine - Yale Church Street Research Unit (CRSU)
-
-
Florida
-
Boca Raton, Florida, 미국, 33486
- Parkinson's Disease and Movement Disorders Center of Boca Raton
-
Gainesville, Florida, 미국, 32608
- Norman Fixel Institute for Neurological Diseases - University of Florida
-
Jacksonville, Florida, 미국, 32224
- Mayo Clinic in Florida
-
Miami, Florida, 미국, 33136
- University of Miami Miller School of Medicine
-
-
Georgia
-
Atlanta, Georgia, 미국, 30329
- Emory University School of Medicine
-
-
Kansas
-
Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center Research Institute
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109
- University of Michigan School of Medicine
-
Farmington Hills, Michigan, 미국, 48334
- Quest Research Institute
-
-
Minnesota
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic - Rochester
-
-
Nebraska
-
Omaha, Nebraska, 미국, 68198
- University of Nebraska Medical Center
-
-
New York
-
New York, New York, 미국, 10032
- Columbia University
-
New York, New York, 미국, 10019
- Icahn School of Medicine at Mount Sinai
-
New York, New York, 미국, 10016
- NYU Langone Health - NYU Dysautonomia Center
-
-
Ohio
-
Cincinnati, Ohio, 미국, 45219
- University of Cincinnati College of Medicine
-
Cleveland, Ohio, 미국, 44195
- Cleveland Clinic
-
Columbus, Ohio, 미국, 43201
- Ohio State University
-
-
Pennsylvania
-
Hershey, Pennsylvania, 미국, 17033
- Penn State University - Milton S. Hershey Medical Center
-
Philadelphia, Pennsylvania, 미국, 19107
- The University of Pennsylvania - Pennsylvania Hospital
-
-
Texas
-
Dallas, Texas, 미국, 75390
- UT Southwestern Medical Center
-
-
Virginia
-
Richmond, Virginia, 미국, 23298
- Virginia Commonwealth University Medical Center
-
-
Washington
-
Kirkland, Washington, 미국, 98034
- Evergreen Health
-
Seattle, Washington, 미국, 98122
- Swedish Neuroscience Institute, Movement Disorders Clinic
-
-
-
-
Aichi-ken
-
Toyoake, Aichi-ken, 일본
- Fujita Health University Hospital
-
-
Kyoto
-
Kyoto, Kyoto, 일본
- National Hospital Organization Utano National Hospital
-
-
Miyagi
-
Sendai, Miyagi, 일본
- National Hospital Organization Sendai Nishitaga Hospital
-
-
Osaka
-
Toyonaka, Osaka, 일본
- National Hospital Organization Osaka Toneyama Medical Center
-
-
Tokyo
-
Fuchū, Tokyo, 일본
- Tokyo Metropolitan Neurological Hospital
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
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).
-
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
-
Patients with an anticipated survival of at least 3 years in the opinion of the Investigator.
-
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.
-
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
위약 비교기: 위약군
|
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 |
|
실험적: ONO-2808 팔
|
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 |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
기간: 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
기간: 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
기간: 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)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Plasma Concentration of ONO-2808
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Project Leader, Ono Pharmaceutical Co., Ltd.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- ONO-2808-03
- jRCT2041230153 (레지스트리 식별자: Japan Registry of Clinical Trials)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .