NCT06848231

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
7mo left

Started Mar 2025

Geographic Reach
3 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

February 17, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 3, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 29, 2026

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

February 17, 2025

Last Update Submit

April 28, 2026

Conditions

Multiple System Atrophy

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of Adverse Events (AEs)

    Incidence and severity of Adverse Events (AEs).

    Baseline to Day 112

Secondary Outcomes (5)

  • Maximum observed concentration (Cmax)

    Baseline to Day 84

  • Area under the concentration-time curve (AUC)

    Baseline to Day 84

  • Time of maximum observed concentration (Tmax)

    Baseline to Day 84

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

    Baseline to Day 112

  • Change from baseline in the 10-meter walking test

    Baseline to Day 112

Study Arms (2)

YA-101

EXPERIMENTAL
Drug: YA-101

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

YA-101DRUG

Drug: YA-101 • YA-101 taken BID

YA-101
PlaceboDRUG

Placebo taken BID

Placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UCLA Health

Los Angeles, California, 90095, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Columbia University Irving medical center

New York, New York, 10032, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Juntendo University Hospital

Tokyo, Japan

RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

National Taiwan University Hospital Cancer Center

Taipei, 106, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Email contact via Dasher Neuroscience Inc.

CONTACT

857-468-9328info@dasherneuroscience.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 26, 2025

Study Start

March 3, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 29, 2026

Record last verified: 2025-06

Locations

US(6)JP(1)TW(2)