Multiple System Atrophy, Parkinson VariantPhase 3NCT07825402
A Trial of ONO-2808 in Participants With the Parkinsonian Subtype of Multiple System Atrophy (MSA-P)
A Phase 3 study testing ONO-2808 in people with Multiple System Atrophy, Parkinson Variant, run by Ono Pharmaceutical Co., Ltd..
Trial summary
The main goal of this clinical trial is to learn if ONO-2808 works to treat adults with the Parkinsonian subtype of Multiple System Atrophy (MSA-P). Researchers will compare ONO-2808 to a placebo (a look-alike substance that contains no drug) to see if ONO-2808 works to treat MSA-P. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Multiple System Atrophy, Parkinson Variant
- 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
- 486 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Oct 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Participants with a diagnosis of clinically established or clinically probable MSA-P according to the 2022 Movement Disorder Society (MDS) criteria for MSA diagnosis.
- Participants in 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-P:
- Parkinsonism
- Orthostatic hypotension
- Urinary dysautonomia
- Participants with an anticipated survival of at least 3 years in the opinion of the Investigator.
Show all 10Show fewer
- Participants 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 (eg, walker or cane) is allowed.
- Ability to swallow oral medication and willingness to adhere to the study drug regimen.
- Normal range of laboratory values at screening and baseline, especially liver function tests.
- Participants receiving treatment (including chronic medications, and herbal or dietary supplements) for symptoms associated with MSA must be on a stable dosage for at least 60 days prior to randomization based on the judgment of the Investigator. Participants must not initiate new treatment within 60 days prior to randomization.
Who cannot join
- Participants with the cerebellar subtype of MSA according to the 2022 MDS criteria for MSA diagnosis.
- Female participants who are pregnant, planning to become pregnant during the study, or breastfeeding.
- Participants with a clinically significant or unstable medical or surgical condition other than MSA-P that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (eg, pulmonary, cardiovascular [including bradyarrhythmia], macular edema, and significant renal or hepatic dysfunction).
- Neurological diseases/disorders other than MSA-P, 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 postencephalitic parkinsonism.
- Any abnormalities, other than MSA, found on the centrally read brain MRI that, in the opinion of the Investigator, may constitute a confounder for the study or preclude safe participation.
- Participants with documented liver diseases, cirrhosis, prior drug-induced liver injury (DILI), or ascites or symptoms and signs of encephalopathy due to hepatic dysfunction.
- Other protocol-defined inclusion and exclusion criteria apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ONO-2808 in Participants With the Parkinsonian Subtype of Multiple System Atrophy (MSA-P)
The main goal of this clinical trial is to learn if ONO-2808 works to treat adults with the Parkinsonian subtype of Multiple System Atrophy (MSA-P). Researchers will compare ONO-2808 to a placebo (a look-alike substance that contains no drug) to see if ONO-2808 works to treat MSA-P.
Participants will:
- Take ONO-2808 or placebo orally for up to 48 weeks
- Make visits to the clinic for checkups and tests
- Answer questions about their health throughout the trial.
- Being tested
- ONO-2808, Placebo
- Keywords
- MSA-P, Parkinson's, Parkinsonian Subtype of, Parkinsonism, MSA, Multiple System Atrophy, Movement Disorder
- Medical subject headings
- Multiple System Atrophy, Parkinson Disease, Parkinsonian Disorders, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-2808Drug
ONO-2808 will be administered to participants orally once daily for 48 weeks.
PlaceboOther
Matching placebo will be administered to participants orally once daily for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ONO-2808 Low Dose | Experimental | Not described Receives: Drug: ONO-2808 |
| ONO-2808 High Dose | Experimental | Not described Receives: Drug: ONO-2808 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in modified United Multiple System Atrophy Rating Scale (mUMSARS) Part I (excluding Item 11) with Collapsed Scoring (0-3)
Measured: Baseline, Week 48
Secondary outcomes (9)
Change from Baseline in Multiple System Atrophy Quality of Life Scale (MSA-QoL) Motor Subscale Score
Measured: Baseline, Week 48
Change from Baseline in Magnetic Resonance Imaging (MRI) Volumetric Assessments
Measured: Baseline, Week 48
Change from Baseline in Total United Multiple System Atrophy Rating Scale (UMSARS) Score (Part I and Part II, all items)
Measured: Baseline, Week 48
Change from Baseline in mUMSARS Score
Measured: Baseline, Week 48
Change from Baseline in MSA-QoL Total Score
Measured: Baseline, Week 48
Change from Baseline in Patient Global Impression of Change (PGI-C) Score
Measured: Baseline, Week 48
Change from Baseline in Patient Global Impression of Severity (PGI-S) Score
Measured: Baseline, Week 48
Change from Baseline in Clinical Global Impression of Change (CGI-C) Score
Measured: Baseline, Week 48
Change from Baseline in Clinical Global Impression of Severity (CGI-S) Score
Measured: Baseline, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System Atrophy, Parkinson VariantStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Deciphera Pharmaceuticals, LLC
- Responsible party
- Sponsor
- Investigators
- Clinical Team, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825402
- Sponsor's protocol ID
- ONO-2808-03-001
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ONO-2808 in Participants With the Parkinsonian Subtype of Multiple System Atrophy (MSA-P)
- ClinicalTrials.gov ID
- NCT07825402
- Acronym / sponsor ID
- ONO-2808-03-001
- Keywords
- MSA-P, Parkinson's, Parkinsonian Subtype of, Parkinsonism, MSA, Multiple System Atrophy, Movement Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Deciphera Pharmaceuticals, LLC
- Study start
- Jan 2027 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this clinical trial is to learn if ONO-2808 works to treat adults with the Parkinsonian subtype of Multiple System Atrophy (MSA-P). Researchers will compare ONO-2808 to a placebo (a look-alike substance that contains no drug) to see if ONO-2808 works to treat MSA-P.
Participants will:
- Take ONO-2808 or placebo orally for up to 48 weeks
- Make visits to the clinic for checkups and tests
- Answer questions about their health throughout the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ONO-2808 Low Dose | Experimental | Drug: ONO-2808 |
| ONO-2808 High Dose | Experimental | Drug: ONO-2808 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants with a diagnosis of clinically established or clinically probable MSA-P according to the 2022 Movement Disorder Society (MDS) criteria for MSA diagnosis.
- Participants in 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-P:
- Participants with an anticipated survival of at least 3 years in the opinion of the Investigator.
- Participants 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 (eg, walker or cane) is allowed.
- Ability to swallow oral medication and willingness to adhere to the study drug regimen.
Key exclusion criteria (7 listed)
- Participants with the cerebellar subtype of MSA according to the 2022 MDS criteria for MSA diagnosis.
- Female participants who are pregnant, planning to become pregnant during the study, or breastfeeding.
- Participants with a clinically significant or unstable medical or surgical condition other than MSA-P that, in the opinion of the Investigator, might preclude safe completion of the study or might affect the results of the study (eg, pulmonary, cardiovascular [including bradyarrhythmia], macular edema, and significant renal or hepatic dysfunction).
- Neurological diseases/disorders other than MSA-P, 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 postencephalitic parkinsonism.
- Any abnormalities, other than MSA, found on the centrally read brain MRI that, in the opinion of the Investigator, may constitute a confounder for the study or preclude safe participation.
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-2808ONO-2808 will be administered to participants orally once daily for 48 weeks. | Drug | ONO-2808 High Dose, ONO-2808 Low Dose |
| PlaceboMatching placebo will be administered to participants orally once daily for 48 weeks. | Other | Placebo |
Primary outcome
Change from Baseline in modified United Multiple System Atrophy Rating Scale (mUMSARS) Part I (excluding Item 11) with Collapsed Scoring (0-3)
Time frame: Baseline, Week 48
9 secondary outcomes
Change from Baseline in Multiple System Atrophy Quality of Life Scale (MSA-QoL) Motor Subscale Score
Time frame: Baseline, Week 48
Change from Baseline in Magnetic Resonance Imaging (MRI) Volumetric Assessments
Time frame: Baseline, Week 48
Change from Baseline in Total United Multiple System Atrophy Rating Scale (UMSARS) Score (Part I and Part II, all items)
Time frame: Baseline, Week 48
Change from Baseline in mUMSARS Score
Time frame: Baseline, Week 48
Change from Baseline in MSA-QoL Total Score
Time frame: Baseline, Week 48
Change from Baseline in Patient Global Impression of Change (PGI-C) Score
Time frame: Baseline, Week 48
Change from Baseline in Patient Global Impression of Severity (PGI-S) Score
Time frame: Baseline, Week 48
Change from Baseline in Clinical Global Impression of Change (CGI-C) Score
Time frame: Baseline, Week 48
Change from Baseline in Clinical Global Impression of Severity (CGI-S) Score
Time frame: Baseline, Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.
Clinical Team study director
Ono Pharmaceutical Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ONO-2808 in people with Multiple System Atrophy, Parkinson Variant, run by Ono Pharmaceutical Co., Ltd..
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 10 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Team (888-724-3274, clinicaltrials@deciphera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in modified United Multiple System Atrophy Rating Scale (mUMSARS) Part I (excluding Item 11) with Collapsed Scoring (0-3) (time frame: Baseline, Week 48). 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 17 Sep 2026.