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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Multiple System Atrophy

In brief

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.

Key facts

Study ID

NCT06848231

Run by

Dasher Neuroscience Inc.

People needed

75

Starts

2025-03-03

Expected to finish

2026-12-31

Last updated by the study team

2026-04-29

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to understand the process of the clinical trial and give informed consent for the participation of the study.
• Diagnosis of MSA according to MDS clinical criteria (Wenning et al, 2022), including subjects with MSA of either subtype (MSA-P or MSA-C).
• Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
• Able to take oral medications.
• Able to ambulate without the assistance of another person.

You may not qualify if…

• Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1.
• Evidence of renal impairment or hepatic impairment.
• Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower.
• 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.
• Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.

Where it is running

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

Full record on ClinicalTrials.gov

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