Multiple System Atrophy (MSA)Phase 2NCT05923866
A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy
A Phase 2 study testing ONO-2808 in people with Multiple System Atrophy (MSA), run by Ono Pharmaceutical Co., Ltd. at 35 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Multiple System Atrophy (MSA)
- What is being tested?
- ONO-2808
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 22 Sep 2023to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States30 sites
University of Michigan School of Medicine
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30329
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43201
UT Southwestern Medical Center
Dallas, Texas, 75390
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, 80113
Quest Research Institute
Farmington Hills, Michigan, 48334
The Parkinson's Movement and Disorder Institute
Fountain Valley, California, 92708
Norman Fixel Institute for Neurological Diseases - University of Florida
Gainesville, Florida, 32608
Penn State University - Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Mayo Clinic in Florida
Jacksonville, Florida, 32224
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
Evergreen Health
Kirkland, Washington, 98034
University of Southern California
Los Angeles, California, 90033
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
University of Miami Miller School of Medicine
Miami, Florida, 33136
Yale School of Medicine - Yale Church Street Research Unit (CRSU)
New Haven, Connecticut, 06519
NYU Langone Health - NYU Dysautonomia Center
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10019
Columbia University
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Stanford University School of Medicine
Palo Alto, California, 94304
The University of Pennsylvania - Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Swedish Neuroscience Institute, Movement Disorders Clinic
Seattle, Washington, 98122
Japan5 sites
Tokyo Metropolitan Neurological Hospital
Fuchū, Tokyo
National Hospital Organization Utano National Hospital
Kyoto, Kyoto
National Hospital Organization Sendai Nishitaga Hospital
Sendai, Miyagi
Fujita Health University Hospital
Toyoake, Aichi-ken
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka, Osaka
About this study
Official title: A Phase 2, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Open-label, Parallel Group Extension Part to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Potential Efficacy of Multiple Doses of ONO-2808 in Patients With Multiple System Atrophy
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.
Read the detailed description
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.
- Conditions
- Multiple System Atrophy (MSA)
- Being tested
- ONO-2808, Placebo
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-2808Drug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| ONO-2808 Arm | Experimental | Not described Receives: Drug: ONO-2808 |
| Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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.
Measured: From screening up to follow-up for the core part (up to Week 28)
Incidence of TEAEs by Highest Severity
A TEAE was defined as any adverse event occurring or worsening on or after the first dose of study treatment.
Measured: From screening up to follow-up for the core part (up to Week 28)
Incidence of Study Treatment-related TEAEs by Highest Severity
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.
Measured: From screening up to follow-up for the core part (up to Week 28)
Secondary outcomes (1)
Plasma Concentration of ONO-2808
Descriptive summary statistics were calculated for ONO-2808 plasma concentrations, by dose level and time point.
Measured: Week 2, Week 8, Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start22 Sep 2023
- Primary completion15 Sep 2025
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple System Atrophy (MSA)Studies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923866
- Sponsor's protocol ID
- ONO-2808-03
- Other IDs
- jRCT2041230153
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2023
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Placebo-controlled, Parallel-group Study Followed by an Open-label, Parallel Group Extension Part to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Potential Efficacy of Multiple Doses of ONO-2808 in Patients With Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT05923866
- Acronym / sponsor ID
- ONO-2808-03
- Conditions
- Multiple System Atrophy (MSA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Posted 6 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-2808 Arm | Experimental | Drug: ONO-2808 |
| Placebo Arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-2808Oral 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 | Drug | ONO-2808 Arm |
| PlaceboOral 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 | Drug | Placebo Arm |
Primary outcome
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: 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.
Incidence of TEAEs by Highest Severity
Time frame: 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.
Incidence of Study Treatment-related TEAEs by Highest Severity
Time frame: 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.
1 secondary outcome
Plasma Concentration of ONO-2808
Time frame: Week 2, Week 8, Week 12, and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-2808 in people with Multiple System Atrophy (MSA), run by Ono Pharmaceutical Co., Ltd. at 35 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (time frame: From screening up to follow-up for the core part (up to Week 28)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.