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Active, not recruitingNCT06848231Updated Aug 19, 2026

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

A Phase 2 interventional study of YA-101 and Placebo in Multiple System Atrophy, sponsored by Dasher Neuroscience Inc.. Active, not recruiting at 9 sites in 3 countries. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Dasher Neuroscience Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

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.

Read the detailed description

The purpose of the study is to evaluate 2 doses of YA-101 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) potential efficacy of YA-101.

02

Conditions studied

  • Multiple System Atrophy
03

In context

Multiple System Atrophy

207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.

This study's planned enrollment of 75 is above the median of 40 across 131 interventional studies indexed under Multiple System Atrophy.

Browse Multiple System Atrophy studies →

Lead sponsor

This is the only study on the registry with Dasher Neuroscience Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    YA-101

    Drug: YA-101

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugYA-101

    Drug: YA-101 • YA-101 taken BID

  • DrugPlacebo

    Placebo taken BID

06

What researchers measure

Primary outcomes

  1. Incidence and severity of Adverse Events (AEs)

    Incidence and severity of Adverse Events (AEs).

    Time frame: Baseline to Day 112

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    To describe the pharmacokinetics parameter (Cmax) of YA-101 using sparse PK sampling.

    Time frame: Baseline to Day 84

  2. Area under the concentration-time curve (AUC)

    To describe the pharmacokinetics parameter (AUC) of YA-101 using sparse PK sampling.

    Time frame: Baseline to Day 84

  3. Time of maximum observed concentration (Tmax)

    To describe the pharmacokinetics parameter (Tmax) of YA-101 using sparse PK sampling.

    Time frame: Baseline to Day 84

  4. Change from baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) over time

    The unified multiple system atrophy rating scale (UMSARS) is composed of four subscales: UMSARS-I (12 items) rates patient-reported functional disability, UMSARS-II (14 items) assesses motor impairment based on a clinical examination, UMSARS-III records blood pressure and heart rate in the supine and standing positions, and UMSARS-IV (1 item) rates chore-based disability. Higher scores on the UMSARS indicate greater disability.

    Time frame: Baseline to Day 112

  5. Change from baseline in the 10-meter walking test

    Time frame: Baseline to Day 112

07

Study locations

9 sites
  • UCLA Health
    Los Angeles, California 90095, United States
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Columbia University Irving medical center
    New York, New York 10032, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Juntendo University Hospital
    Tokyo, Japan
  • National Taiwan University Hospital
    Taipei, 100225, Taiwan
  • National Taiwan University Hospital Cancer Center
    Taipei, 106, Taiwan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06848231
Lead sponsor
Dasher Neuroscience Inc.
Responsible party
Sponsor
First posted
Feb 26, 2025
Start date
Mar 3, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 19, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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