Active, not recruitingPhase 2
A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy
Key facts
- Who runs it
- Dasher Neuroscience Inc.
- Where
- Boston, Houston, Los Angeles, Nashville, New York, and Rochester, United StatesSee the 6 sitesAlso in 2 other countries, 3 sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 2
- People taking part
- 75 people, planned
- Started
- 3 Mar 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- YA-101
- Placebo
- Record updated
- 19 August 2026
Who can take part
- Age
- 30 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1
- 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
- Evidence of renal impairment or hepatic impairment
- Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
- Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower
Where in United States
Also in 2 other countries, 3 sites
- Brigham and Women's HospitalBoston, United StatesNo longer taking part
- Baylor College of MedicineHouston, United StatesNo longer taking part
- UCLA HealthLos Angeles, United StatesNo longer taking part
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- Columbia University Irving Medical CenterNew York, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- YA-101Treatment being tested
- PlaceboPlacebo, for comparison
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 19 August 2026