Actively Recruiting
A Double-Blind, Placebo-Controlled, Multi-Center, Phase II Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of YA-101 in Multiple System Atrophy
Led by Dasher Neuroscience Inc. · Updated on 2026-04-29
75
Participants Needed
9
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and potential effectiveness of YA-101 in people with multiple system atrophy (MSA), a rare neurological condition. This Phase 2, double-blind, placebo-controlled, multi-center study aims to compare two doses of YA-101 against a placebo. The study is designed to gather important information on how the drug behaves in the body and its impact on symptoms of MSA. Participants will be randomly assigned to receive either YA-101 or a placebo, both taken twice daily. The study includes a dose escalation approach to assess the effects of different doses. The treatment period lasts up to 112 days, during which safety and response to the drug will be closely monitored. During the trial, participants will have regular assessments including evaluations of adverse events, drug concentration in the blood, and changes in MSA symptoms using scales such as the Unified Multiple System Atrophy Rating Scale and a 10-meter walking test. Safety tests will also be conducted to track any side effects. The total study participation spans from baseline through Day 112, with careful monitoring to understand the drug's effects and tolerability.
CONDITIONS
Brief Title
A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the clinical trial process and provide informed consent
- Diagnosis of multiple system atrophy (MSA) by MDS clinical criteria, including MSA-P or MSA-C subtypes
- Male or non-pregnant, non-lactating female with no child-bearing potential or agrees to use two forms of contraception
- Able to take oral medications
- Able to walk without assistance from another person
You will not qualify if you...
- Positive urine or alcohol test at screening and Day 1
- Evidence of kidney or liver impairment
- Mini-Mental State Examination (MMSE) score of 24 or lower
- History of severe systemic diseases such as cardiopulmonary failure, severe liver or kidney disease, uncontrolled diabetes; major central nervous system disorders like stroke, encephalitis, epilepsy, or severe head trauma; peptic ulcer within a year prior to screening
- Positive test for active viral infections including HIV, hepatitis B, or hepatitis C
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 16 weeks (up to Day 112)
Participants receive either YA-101 or placebo taken twice daily to evaluate safety, tolerability, and potential efficacy.
Weekly visits for up to 16 weeks
Trial Site Locations
Total: 9 locations
1
UCLA Health
Los Angeles, California, United States, 90095
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Columbia University Irving medical center
New York, New York, United States, 10032
Actively Recruiting
5
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
6
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
7
Juntendo University Hospital
Tokyo, Japan
Actively Recruiting
8
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
9
National Taiwan University Hospital Cancer Center
Taipei, Taiwan, 106
Not Yet Recruiting
Research Team
E
Email contact via Dasher Neuroscience Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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