What side effects are associated with this type of intervention?

Common treatments for Multiple System Atrophy (MSA) include medications like levodopa, which can cause motor complications such as dyskinesia, wearing-off, and on-off phenomena. Other treatments aimed at managing autonomic dysfunction and motor impairments may lead to side effects including dizziness, somnolence, and gastrointestinal issues. As ONO-2808 is still under investigation, its specific side effects are not yet fully known, but it is being studied for its safety and tolerability in MSA patients.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Multiple System Atrophy (MSA). Treatment typically focuses on managing symptoms, such as using medications to control blood pressure, bladder function, and motor symptoms. Drugs like levodopa, used for Parkinson's disease, may be prescribed to help with motor symptoms, although their effectiveness in MSA is limited. Research, including the study of ONO-2808, is ongoing to find more targeted therapies for MSA.

What other types of research exist?

Promising novel alternatives to ONO-2808 for Multiple System Atrophy patients include: 1) HDAC6 inhibitors like ACY-1215, which have shown potential in improving motor and sensory nerve conduction. 2) Rho kinase inhibitors like Y-27632, which have demonstrated improved motor function in neurodegenerative disease models. 3) Pharmacological inhibitors of nSMase2, such as DDL-112, which reduce α-synuclein pathology and improve motor function in Parkinson's disease models. These alternatives target neuroprotection and motor function improvement, which are critical in MSA treatment.

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ONO-2808 for Multiple System Atrophy

Phase 2

Recruiting

Research Sponsored by Ono Pharmaceutical Co. Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 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.

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, week 8, week 12, and week 24

Summary

This trial is testing a new drug called ONO-2808 in patients with Multiple System Atrophy (MSA). The study aims to see if the drug is safe, how it behaves in the body, and whether it can improve symptoms of MSA. Researchers are comparing three different doses of ONO-2808.

Who is the study for?

This trial is for patients with Multiple System Atrophy (MSA) who can walk unassisted, have had symptoms like Parkinsonism or ataxia for no more than 5 years, and are expected to live at least another 3 years. They must be able to swallow pills and not have other serious health issues or neurological disorders besides MSA.

What is being tested?

The study tests ONO-2808 against a placebo in people with MSA. It's double-blind, meaning neither the participants nor the researchers know who gets the real drug. The goal is to check if ONO-2808 is safe and how it affects the body compared to a dummy pill.

What are the potential side effects?

Since this is the first test of ONO-2808 in humans with MSA, specific side effects aren't listed yet. Generally, potential side effects could include reactions where you take the medicine, stomach issues, fatigue, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with MSA according to the latest criteria.

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I can walk at least 20 steps on my own, even with a walker or cane.

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I can take pills and will follow the study's treatment plan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have Parkinson's, dementia with Lewy bodies, or similar neurological conditions.

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I have a liver disease or cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2, week 8, week 12, and week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2, week 8, week 12, and week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, week 8, week 12, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

12-lead electrocardiograms (ECGs); parameters such as, but not limited to, heart rate, RR, PR, QRS, QT, and corrected QT intervals (QTcF)

Clinical laboratory abnormalities (hematology, clinical chemistry, and urinalysis)

Clinically-abnormal findings in the Columbia Suicide Severity Rating Scale (C-SSRS)

+6 more

Secondary study objectives

ONO-2808 concentration in cerebrospinal fluid (CSF)

Plasma concentration of ONO-2808

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ONO-2808 ArmExperimental Treatment1 Intervention

Group II: Placebo ArmPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ONO-2808

2020

Completed Phase 1

~100

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple System Atrophy (MSA) is a progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and ataxia. Common treatments for MSA include medications that address its symptoms, such as autonomic dysfunction and motor impairments. For instance, drugs like midodrine and fludrocortisone are used to manage orthostatic hypotension by increasing blood pressure. Levodopa is sometimes used to alleviate parkinsonian symptoms, although its effectiveness is limited in MSA compared to Parkinson's disease. The trial ONO-2808 is investigating a new treatment, and while specific details on its mechanism are not provided, it is likely focused on modulating pathways involved in neurodegeneration or symptom management. Understanding these mechanisms is crucial for MSA patients as it helps in targeting the underlying disease processes and improving quality of life by managing debilitating symptoms.