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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, week 8, week 12, and week 24
Awards & highlights

Study Summary

This trial will test a new drug for Multiple System Atrophy, a rare neurological disorder, to see if it's safe, effective, and has no side effects.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdLead Sponsor
154 Previous Clinical Trials
94,443 Total Patients Enrolled
Project LeaderStudy DirectorOno Pharma USA Inc
12 Previous Clinical Trials
2,533 Total Patients Enrolled

Media Library

ONO-2808 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05923866 — Phase 2
Multiple System Atrophy Research Study Groups: ONO-2808 Arm, Placebo Arm
Multiple System Atrophy Clinical Trial 2023: ONO-2808 Highlights & Side Effects. Trial Name: NCT05923866 — Phase 2
ONO-2808 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05923866 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for people to participate in this experiment?

"Sadly, per the clinicaltrials.gov entry for this trial, it is not currently accepting new participants as recruitment concluded on June 20th of this year. Despite that unfortunate news, there are still a total of 192 other trials actively recruiting patients at present."

Answered by AI

Does this medical study accept participants over the age of forty?

"As enumerated in the enrollment parameters, eligible participants must be between 30 and 80 years of age."

Answered by AI

Has the ONO-2808 Arm been granted authorization by the Food and Drug Administration?

"The safety rating of ONO-2808 Arm was assessed at a score of 2, as this is only Phase 2 trial and there has been no evidence to show its efficacy. However, there have been multiple studies conducted that have suggested the drug's relative safeness."

Answered by AI

Am I eligible to contribute to this experiment?

"Candidates with multiple system atrophy between the ages of 30 and 80 may apply for this medical trial. Approximately 80 participants are needed to complete it."

Answered by AI

Who else is applying?

What site did they apply to?
The Parkinson's Movement and Disorder Institute
Parkinson's Disease Treatment Center of SW Florida
Quest Research Institute
Other
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I'm hoping a clinical trial will address my condition. Open to slow down progression of disease NYU no taking new patients.
PatientReceived no prior treatments
I've been unsuccessful in finding a clinical trial accepting patients with symptoms more than 4 years.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy
2023. "A Phase 2 Study of ONO-2808 in Patients With Multiple System Atrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05923866.
All > Multiple System Atrophy
~53 spots leftby Aug 2025
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