En fas 2-studie av ONO-2808 hos patienter med multipelsystematrofi
En fas 2, dubbelblind, placebokontrollerad, parallellgruppsstudie för att bedöma säkerhet, tolerabilitet, farmakokinetik, farmakodynamik och potentiell effekt av flera doser av ONO-2808 hos patienter med multipel systematrofi (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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
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California
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Fountain Valley, California, Förenta staterna, 92708
- The Parkinson's Movement and Disorder Institute
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Los Angeles, California, Förenta staterna, 90033
- University of Southern California
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Los Angeles, California, Förenta staterna, 90095
- David Geffen School of Medicine at UCLA
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Palo Alto, California, Förenta staterna, 94304
- Stanford University School of Medicine
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Colorado
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Englewood, Colorado, Förenta staterna, 80113
- CenExel Rocky Mountain Clinical Research
-
-
Connecticut
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New Haven, Connecticut, Förenta staterna, 06519
- Yale School of Medicine - Yale Church Street Research Unit (CRSU)
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Florida
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Boca Raton, Florida, Förenta staterna, 33486
- Parkinson's Disease and Movement Disorders Center of Boca Raton
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Gainesville, Florida, Förenta staterna, 32608
- Norman Fixel Institute for Neurological Diseases - University of Florida
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Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic in Florida
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Miami, Florida, Förenta staterna, 33136
- University of Miami Miller School of Medicine
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-
Georgia
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Atlanta, Georgia, Förenta staterna, 30329
- Emory University School of Medicine
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160
- University of Kansas Medical Center Research Institute
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- University of Michigan School of Medicine
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Farmington Hills, Michigan, Förenta staterna, 48334
- Quest Research Institute
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-
Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic - Rochester
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-
Nebraska
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Omaha, Nebraska, Förenta staterna, 68198
- University of Nebraska Medical Center
-
-
New York
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New York, New York, Förenta staterna, 10032
- Columbia University
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New York, New York, Förenta staterna, 10019
- Icahn School of Medicine at Mount Sinai
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New York, New York, Förenta staterna, 10016
- NYU Langone Health - NYU Dysautonomia Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45219
- University of Cincinnati College of Medicine
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic
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Columbus, Ohio, Förenta staterna, 43201
- Ohio State University
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Pennsylvania
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Hershey, Pennsylvania, Förenta staterna, 17033
- Penn State University - Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- The University of Pennsylvania - Pennsylvania Hospital
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Texas
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Dallas, Texas, Förenta staterna, 75390
- UT Southwestern Medical Center
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Virginia
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Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University Medical Center
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Washington
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Kirkland, Washington, Förenta staterna, 98034
- Evergreen Health
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Seattle, Washington, Förenta staterna, 98122
- Swedish Neuroscience Institute, Movement Disorders Clinic
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Aichi-ken
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Toyoake, Aichi-ken, Japan
- Fujita Health University Hospital
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Kyoto
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Kyoto, Kyoto, Japan
- National Hospital Organization Utano National Hospital
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Miyagi
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Sendai, Miyagi, Japan
- National Hospital Organization Sendai Nishitaga Hospital
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Osaka
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Toyonaka, Osaka, Japan
- National Hospital Organization Osaka Toneyama Medical Center
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Tokyo
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Fuchū, Tokyo, Japan
- Tokyo Metropolitan Neurological Hospital
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placeboarm
|
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 |
|
Experimentell: ONO-2808 Arm
|
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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Plasma Concentration of ONO-2808
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Project Leader, Ono Pharmaceutical Co., Ltd.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ONO-2808-03
- jRCT2041230153 (Registeridentifierare: Japan Registry of Clinical Trials)
Plan för individuella deltagardata (IPD)
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