Vaiheen 2 tutkimus ONO-2808:sta potilailla, joilla on monisysteeminen atrofia
Vaihe 2, kaksoissokkoutettu, lumekontrolloitu, rinnakkaisryhmätutkimus ONO-2808:n useiden annosten turvallisuuden, siedettävyyden, farmakokinetiikkaa, farmakodynamiikkaa ja mahdollista tehoa varten potilailla, joilla on monijärjestelmäatrofia (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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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Aichi-ken
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Toyoake, Aichi-ken, Japani
- Fujita Health University Hospital
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Kyoto
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Kyoto, Kyoto, Japani
- National Hospital Organization Utano National Hospital
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Miyagi
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Sendai, Miyagi, Japani
- National Hospital Organization Sendai Nishitaga Hospital
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Osaka
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Toyonaka, Osaka, Japani
- National Hospital Organization Osaka Toneyama Medical Center
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Tokyo
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Fuchū, Tokyo, Japani
- Tokyo Metropolitan Neurological Hospital
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California
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Fountain Valley, California, Yhdysvallat, 92708
- The Parkinson's Movement and Disorder Institute
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Los Angeles, California, Yhdysvallat, 90033
- University of Southern California
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Los Angeles, California, Yhdysvallat, 90095
- David Geffen School of Medicine at UCLA
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Palo Alto, California, Yhdysvallat, 94304
- Stanford University School of Medicine
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Colorado
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Englewood, Colorado, Yhdysvallat, 80113
- CenExel Rocky Mountain Clinical Research
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Connecticut
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New Haven, Connecticut, Yhdysvallat, 06519
- Yale School of Medicine - Yale Church Street Research Unit (CRSU)
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Florida
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Boca Raton, Florida, Yhdysvallat, 33486
- Parkinson's Disease and Movement Disorders Center of Boca Raton
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Gainesville, Florida, Yhdysvallat, 32608
- Norman Fixel Institute for Neurological Diseases - University of Florida
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Jacksonville, Florida, Yhdysvallat, 32224
- Mayo Clinic in Florida
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Miami, Florida, Yhdysvallat, 33136
- University of Miami Miller School of Medicine
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30329
- Emory University School of Medicine
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Kansas
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Kansas City, Kansas, Yhdysvallat, 66160
- University of Kansas Medical Center Research Institute
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Yhdysvallat, 02114
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48109
- University of Michigan School of Medicine
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Farmington Hills, Michigan, Yhdysvallat, 48334
- Quest Research Institute
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Minnesota
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Rochester, Minnesota, Yhdysvallat, 55905
- Mayo Clinic - Rochester
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Nebraska
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Omaha, Nebraska, Yhdysvallat, 68198
- University of Nebraska Medical Center
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New York
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New York, New York, Yhdysvallat, 10032
- Columbia University
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New York, New York, Yhdysvallat, 10019
- Icahn School of Medicine at Mount Sinai
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New York, New York, Yhdysvallat, 10016
- NYU Langone Health - NYU Dysautonomia Center
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Ohio
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Cincinnati, Ohio, Yhdysvallat, 45219
- University of Cincinnati College of Medicine
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Cleveland, Ohio, Yhdysvallat, 44195
- Cleveland Clinic
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Columbus, Ohio, Yhdysvallat, 43201
- Ohio State University
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Pennsylvania
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Hershey, Pennsylvania, Yhdysvallat, 17033
- Penn State University - Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Yhdysvallat, 19107
- The University of Pennsylvania - Pennsylvania Hospital
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Texas
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Dallas, Texas, Yhdysvallat, 75390
- UT Southwestern Medical Center
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Virginia
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Richmond, Virginia, Yhdysvallat, 23298
- Virginia Commonwealth University Medical Center
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Washington
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Kirkland, Washington, Yhdysvallat, 98034
- Evergreen Health
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Seattle, Washington, Yhdysvallat, 98122
- Swedish Neuroscience Institute, Movement Disorders Clinic
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Placebo Comparator: Placebo Arm
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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 |
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Kokeellinen: ONO-2808 Varsi
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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 |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Aikaikkuna: 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
Aikaikkuna: From screening up to follow-up for the core part (up to Week 28)
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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
Aikaikkuna: From screening up to follow-up for the core part (up to Week 28)
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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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Plasma Concentration of ONO-2808
Aikaikkuna: Week 2, Week 8, Week 12, and Week 24
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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
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Project Leader, Ono Pharmaceutical Co., Ltd.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- ONO-2808-03
- jRCT2041230153 (Rekisterin tunniste: Japan Registry of Clinical Trials)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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