Multiple System AtrophyPhase 2NCT06848231
A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy
A Phase 2 study testing YA-101 in people with Multiple System Atrophy, run by Dasher Neuroscience Inc. at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- YA-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 3 Mar 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States6 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Baylor College of Medicine
Houston, Texas, 77030
UCLA Health
Los Angeles, California, 90095
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University Irving medical center
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55905
Taiwan2 sites
National Taiwan University Hospital
Taipei, 100225
National Taiwan University Hospital Cancer Center
Taipei, 106
About this study
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
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.
Read the 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.
- Conditions
- Multiple System Atrophy
- Being tested
- YA-101, Placebo
- Medical subject headings
- Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YA-101Drug
Drug: YA-101
- YA-101 taken BID
PlaceboDrug
Placebo taken BID
| Study group | Role | What they receive |
|---|---|---|
| YA-101 | Experimental | Not described Receives: Drug: YA-101 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events (AEs)
Incidence and severity of Adverse Events (AEs).
Measured: Baseline to Day 112
Secondary outcomes (5)
Maximum observed concentration (Cmax)
To describe the pharmacokinetics parameter (Cmax) of YA-101 using sparse PK sampling.
Measured: Baseline to Day 84
Area under the concentration-time curve (AUC)
To describe the pharmacokinetics parameter (AUC) of YA-101 using sparse PK sampling.
Measured: Baseline to Day 84
Time of maximum observed concentration (Tmax)
To describe the pharmacokinetics parameter (Tmax) of YA-101 using sparse PK sampling.
Measured: Baseline to Day 84
Change from baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) over time
The unified multiple system atrophy rating scale (UMSARS) is composed of four subscales: UMSARS-I (12 items) rates patient-reported functional disability, UMSARS-II (14 items) assesses motor impairment based on a clinical examination, UMSARS-III records blood pressure and heart rate in the supine and standing positions, and UMSARS-IV (1 item) rates chore-based disability. Higher scores on the UMSARS indicate greater disability.
Measured: Baseline to Day 112
Change from baseline in the 10-meter walking test
Measured: Baseline to Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start3 Mar 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasher Neuroscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848231
- Sponsor's protocol ID
- YA-101-201
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06848231
- Acronym / sponsor ID
- YA-101-201
- Conditions
- Multiple System Atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Dasher Neuroscience Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YA-101 | Experimental | Drug: YA-101 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YA-101Drug: YA-101 • YA-101 taken BID | Drug | YA-101 |
| PlaceboPlacebo taken BID | Drug | Placebo |
Primary outcome
Incidence and severity of Adverse Events (AEs)
Time frame: Baseline to Day 112
Incidence and severity of Adverse Events (AEs).
5 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Baseline to Day 84
Area under the concentration-time curve (AUC)
Time frame: Baseline to Day 84
Time of maximum observed concentration (Tmax)
Time frame: Baseline to Day 84
Change from baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) over time
Time frame: Baseline to Day 112
Change from baseline in the 10-meter walking test
Time frame: Baseline to Day 112
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YA-101 in people with Multiple System Atrophy, run by Dasher Neuroscience Inc. at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Taiwan, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AEs) (time frame: Baseline to Day 112). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.