Clinical Trials in the USA / NCT06848231
Active, not recruiting
Phase 2
A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy
NCT06848231 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Multiple System Atrophy
Investigational drug(s) / intervention(s)
YA-101Placebo
YA-101: Drug: YA-101 • YA-101 taken BID
Placebo: Placebo taken BID
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.
Eligibility
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:
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.
Primary outcome measure(s)
- Incidence and severity of Adverse Events (AEs) — Baseline to Day 112
Incidence and severity of Adverse Events (AEs).
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLA Health | Los Angeles | California | |
| Brigham and Women's Hospital | Boston | Massachusetts | |
| Mayo Clinic | Rochester | Minnesota | |
| Columbia University Irving medical center | New York | New York | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| Baylor College of Medicine | Houston | Texas | |
| Juntendo University Hospital | Tokyo | Japan | |
| National Taiwan University Hospital | Taipei | Taiwan | |
| National Taiwan University Hospital Cancer Center | Taipei | Taiwan |
Other trials for the same condition
An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
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GDNF Gene Therapy for Multiple System Atrophy
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A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06848231 on ClinicalTrials.gov ↗ ← All trials in the USA