RecruitingPhase 2

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

United States75 participantsStarted 2025-03-03

Plain-language 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.

Who can participate

Age range30 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Incidence and severity of Adverse Events (AEs)

Timeframe: Baseline to Day 112

Trial details

NCT IDNCT06848231

SponsorDasher Neuroscience Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Email contact via Dasher Neuroscience Inc.

857-468-9328 info@dasherneuroscience.com

View on ClinicalTrials.gov More Multiple System Atrophy trials