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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
Awards & highlights
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 belowSelect...
I have been diagnosed with MSA according to the latest criteria.
Select...
I can walk at least 20 steps on my own, even with a walker or cane.
Select...
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:Select...
I do not have Parkinson's, dementia with Lewy bodies, or similar neurological conditions.
Select...
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
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 moreSecondary 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
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.
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Who is running the clinical trial?
Ono Pharmaceutical Co. LtdLead Sponsor
169 Previous Clinical Trials
95,577 Total Patients Enrolled
Project LeaderStudy DirectorOno Pharma USA Inc
23 Previous Clinical Trials
3,286 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with MSA according to the latest criteria.I can walk at least 20 steps on my own, even with a walker or cane.I have a liver disease or cirrhosis.I do not have any serious health issues that could interfere with the study.I do not have Parkinson's, dementia with Lewy bodies, or similar neurological conditions.Your total score on the Unified Multiple System Atrophy Rating Scale (UMSARS) 1, excluding sexual function, is 17 or lower.You have active infections with viruses like HIV, hepatitis B, or hepatitis C.You have had thoughts of hurting yourself or have tried to hurt yourself in the past 6 months.I can take pills and will follow the study's treatment plan.My MSA symptoms started no more than 5 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: ONO-2808 Arm
- Group 2: Placebo Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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