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Clinical Trials in Japan / NCT06848231
Active, not recruiting Phase 2

A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy

NCT06848231 · tracked via the Priya Life Science Japan tracker
Sponsor
Dasher Neuroscience Inc
Phase
Phase 2
Started
2025-03-03
Last updated
2026-08-19

Condition(s) studied

Multiple System Atrophy

Investigational drug(s) / intervention(s)

YA-101Placebo

YA-101: Drug: YA-101 • YA-101 taken BID

Placebo: Placebo taken BID

Study summary

This is a Phase 2, double-blind, placebo-controlled, multi-center, Phase II, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of Ya-101 in subjects with multiple system atrophy.

Eligibility

Sex
ALL
Min age
30 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Able to understand the process of the clinical trial and give informed consent for the participation of the study. 2. Diagnosis of MSA according to MDS clinical criteria (Wenning et al, 2022), including subjects with MSA of either subtype (MSA-P or MSA-C). 3. Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception. 4. Able to take oral medications. 5. Able to ambulate without the assistance of another person. Exclusion Criteria: 1. Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1. 2. Evidence of renal impairment or hepatic impairment. 3. Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower. 4. Medical history includes severe systemic diseases such as cardiopulmonary failure, severe liver or kidney disease, and uncontrolled diabetes; significant central nervous system disorders like stroke, encephalitis, and epilepsy and severe head trauma; peptic ulcer in one year prior to screening. 5. Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.

Primary outcome measure(s)

  • Incidence and severity of Adverse Events (AEs) — Baseline to Day 112
    Incidence and severity of Adverse Events (AEs).

Trial sites (9)

FacilityCityRegionStatus
UCLA Health Los Angeles California
Brigham and Women's Hospital Boston Massachusetts
Mayo Clinic Rochester Minnesota
Columbia University Irving medical center New York New York
Vanderbilt University Medical Center Nashville Tennessee
Baylor College of Medicine Houston Texas
Juntendo University Hospital Tokyo Japan
National Taiwan University Hospital Taipei Taiwan
National Taiwan University Hospital Cancer Center Taipei Taiwan

Other trials for the same condition

A Study of Lu AF82422 in Participants With Multiple System Atrophy Active, not recruiting
Systematic Assessment of Laryngopharyngeal Function in Patients With Neurodegenerative Diseases Recruiting
A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA) Active, not recruiting
An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy Recruiting
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06848231 on ClinicalTrials.gov ↗ ← All trials in Japan