Status:
RECRUITING
A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy
Lead Sponsor:
Dasher Neuroscience Inc.
Conditions:
Multiple System Atrophy
Eligibility:
All Genders
30+ years
Phase:
PHASE2
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 multip...
Detailed Description
The purpose of the study is to evaluate 2 doses of YA-101 compared to placebo in MSA patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) potential efficacy of YA-101.
Eligibility Criteria
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.
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06848231
Start Date
March 3 2025
End Date
December 31 2026
Last Update
September 10 2025
Active Locations (9)
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1
UCLA Health
Los Angeles, California, United States, 90095
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Columbia University Irving medical center
New York, New York, United States, 10032