NCT06848231 A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy
| NCT ID | NCT06848231 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dasher Neuroscience Inc. |
| Condition | Multiple System Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2025-03-03 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 multiple system atrophy.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06848231 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Multiple System Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06848231 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06848231 currently recruiting?
Yes, NCT06848231 is actively recruiting participants. Contact the research team at info@dasherneuroscience.com for enrollment information.
Where is the NCT06848231 trial being conducted?
This trial is being conducted at Los Angeles, United States, Boston, United States, Rochester, United States, New York, United States and 5 additional locations.
Who is sponsoring the NCT06848231 clinical trial?
NCT06848231 is sponsored by Dasher Neuroscience Inc.. The trial plans to enroll 75 participants.