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A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy

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ClinicalTrials.gov Identifier: NCT05923866
Recruitment Status : Recruiting
First Posted : June 28, 2023
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple System Atrophy (MSA) Drug: ONO-2808 Drug: Placebo Phase 2

Detailed Description:
The purpose of the study 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Potential Efficacy of Multiple Doses of ONO-2808 in Patients With Multiple System Atrophy (MSA)
Actual Study Start Date : September 22, 2023
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ONO-2808 Arm Drug: ONO-2808
Oral administration of ONO-2808 at low, middle or high doses once a daily for 24 weeks
Placebo Comparator: Placebo Arm Drug: Placebo
Oral administration of placebo once a daily for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) [ Time Frame: From screening up to follow-up (Week 28) ]
    Incidence of TEAEs, drug-related TEAEs, TEAEs resulting in study treatment discontinuation, TESAEs, and drug-related TESAEs will be tabulated by system organ class (SOC), preferred term (PT), and severity.

  2. Vital signs (blood pressure) [ Time Frame: From screening up to follow-up (Week 28) ]
    Summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.

  3. Vital signs (pulse rate) [ Time Frame: From screening up to follow-up (Week 28) ]
    Summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.

  4. Vital signs (temperature) [ Time Frame: From screening up to follow-up (Week 28) ]
    Summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.

  5. Vital signs (respiratory rate) [ Time Frame: From screening up to follow-up (Week 28) ]
    Summaries of clinically significant and non-clinically significant abnormalities will be provided by each time point.

  6. 12-lead electrocardiograms (ECGs); parameters such as, but not limited to, heart rate, RR, PR, QRS, QT, and corrected QT intervals (QTcF) [ Time Frame: From screening up to follow-up (Week 28) ]
    The number of patients with normal, abnormal not clinically significant and abnormal clinically significant of ECG results will be tabulated at each time point.

  7. Clinically-significant abnormal physical examination findings [ Time Frame: From screening up to follow-up (Week 28) ]
    The number of patients with normal, abnormal not clinically significant and abnormal clinically significant of physical examination results will be tabulated at each time point.

  8. Clinical laboratory abnormalities (hematology, clinical chemistry, and urinalysis) [ Time Frame: From screening up to follow-up (Week 28) ]
    The number of patients with abnormal laboratory results at any time during the study will be tabulated.

  9. Clinically-abnormal findings in the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: From screening up to follow-up (Week 28) ]
    Responses to the suicidality assessment scale (C-SSRS) will be listed.


Secondary Outcome Measures :
  1. Plasma concentration of ONO-2808 [ Time Frame: Week 2, Week 8, Week 12, and Week 24 ]
    Descriptive summary statistics will be calculated for ONO-2808 plasma concentrations, by dose level and time point.

  2. ONO-2808 concentration in cerebrospinal fluid (CSF) [ Time Frame: Week 24 ]
    Descriptive summary statistics will be calculated for ONO-2808 CSF concentrations, by dose level and time point.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).

  2. 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
  3. Patients with an Unified Multiple System Atrophy Rating Scale (UMSARS) 1 total score (excluding item 1.11 sexual function) of ≤ 17.
  4. Patients with an anticipated survival of at least 3 years in the opinion of the Investigator.
  5. 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.
  6. Ability to swallow oral medication and be willing to adhere to the study intervention regimen.

Exclusion Criteria:

  1. Pregnant or lactating females.
  2. 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).
  3. 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.
  4. Patients with documented liver diseases or cirrhosis.
  5. 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).
  6. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05923866


Contacts
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Contact: Ono Pharma USA, Inc. clinical_trial@ono-pharma.com

Locations
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United States, California
The Parkinson's Movement and Disorder Institute Recruiting
Fountain Valley, California, United States, 92708
Contact: Karina Vargas    714-378-5076    kv@pmdi.org   
Principal Investigator: Daniel D. Truong         
United States, Colorado
CenExel Rocky Mountain Clinical Research Recruiting
Englewood, Colorado, United States, 80113
Contact: Karen Ortiz       k.ortiz@cenexel.com   
Principal Investigator: Rajeev Kumar         
United States, Connecticut
Yale School of Medicine - Yale Church Street Research Unit (CRSU) Recruiting
New Haven, Connecticut, United States, 06519
Contact: Maxine Kuang    203-292-0851    maxine.kuang@yale.edu   
Contact: Nikole Rudenko       nikole.rudenko@yale.edu   
Principal Investigator: Veronica Santini         
United States, Florida
Parkinson's Disease and Movement Disorders Center Recruiting
Boca Raton, Florida, United States, 33486
Contact: Darya Hodaei       info@parkinsonscenter.org   
Principal Investigator: Stuart H. Isaacson         
Norman Fixel Institute for Neurological Diseases - University of Florida Active, not recruiting
Gainesville, Florida, United States, 32608
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Zoe Parrales       parrales.zoe@mayo.edu   
Principal Investigator: Zbigniew K. Wszolek         
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Lucila Hernandez    305-243-1160    lmh245@med.miami.edu   
Contact: Claudia E. Cano    305-243-3530    c.cano@med.miami.edu   
Principal Investigator: Carlos Singer         
Parkinson's Disease Treatment Center of SW Florida Active, not recruiting
Port Charlotte, Florida, United States, 33980
United States, Kansas
University of Kansas Medical Center Research Institute Active, not recruiting
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Arjun Laud    617-726-4923    alaud@mgh.harvard.edu   
Principal Investigator: Anne-Marie Wills         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Diego Rodriguez       drodriguez29@bwh.harvard.edu   
Principal Investigator: Barbara K. Changizi         
United States, Michigan
Quest Research Institute Active, not recruiting
Farmington Hills, Michigan, United States, 48334
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Melanie McFarland    402-559-5134    memcfarland@unmc.edu   
Contact: Sheryl Houston    303-895-1528    sheryl.houston@unmc.edu   
Principal Investigator: Mara Seier         
United States, Pennsylvania
The University of Pennsylvania - Pennsylvania Hospital Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Luis Madrigal    214-648-7494    luis.madrigal@utsouthwestern.edu   
Principal Investigator: Padraig O'Suilleabhain         
United States, Washington
Swedish Neuroscience Institute, Movement Disorders Clinic Recruiting
Seattle, Washington, United States, 98122
Contact: Maria Manzueta    206-618-1271    maria.manzueta@swedish.org   
Contact: Kelly Robertson    206-215-2843    kelly.robertson@swedish.org   
Principal Investigator: Pravin Khemani         
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Project Leader Ono Pharma USA Inc
More Information
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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT05923866    
Other Study ID Numbers: ONO-2808-03
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
 Brain Diseases
Central Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases