ClinicalTrialsFinder
RecruitingPhase 2NCT06848231

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

A 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

Sponsor

Dasher Neuroscience Inc.

Enrollment

75 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple System Atrophy

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

Min Age: 30 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria5

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGYA-101

Drug: YA-101 • YA-101 taken BID

DRUGPlacebo

Placebo taken BID

Locations(9)

UCLA Health

Los Angeles, California, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University Irving medical center

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Juntendo University Hospital

Tokyo, Japan

National Taiwan University Hospital

Taipei, Taiwan

National Taiwan University Hospital Cancer Center

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06848231

Related Trials

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ION464 Administered to Adults With Multiple System Atrophy (HORIZON)

NCT0416548615 locations

Comprehensive Swallowing Rehabilitation in Patients With MSA

NCT047822841 location

An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy

NCT0719786615 locations

A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy

NCT0656823754 locations

Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms

NCT057480289 locations