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Active, not recruiting

NCT Number: NCT06848231

A Phase 2 Study of YA-101 in Patients 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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple System Atrophy Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Primary Dysautonomias Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Juntendo University Hospital, Tokyo, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

YA-101

Drug

Drug: YA-101

  • YA-101 taken BID

Placebo

Drug

Placebo taken BID

Primary outcomes

  1. Incidence and severity of Adverse Events (AEs)

    Time frame: Baseline to Day 112

    Incidence and severity of Adverse Events (AEs).

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Baseline to Day 84

    To describe the pharmacokinetics parameter (Cmax) of YA-101 using sparse PK sampling.

  2. Area under the concentration-time curve (AUC)

    Time frame: Baseline to Day 84

    To describe the pharmacokinetics parameter (AUC) of YA-101 using sparse PK sampling.

  3. Time of maximum observed concentration (Tmax)

    Time frame: Baseline to Day 84

    To describe the pharmacokinetics parameter (Tmax) of YA-101 using sparse PK sampling.

  4. Change from baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) over time

    Time frame: Baseline to Day 112

    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.

  5. Change from baseline in the 10-meter walking test

    Time frame: Baseline to Day 112

Sponsors and collaborators

Lead sponsor

Dasher Neuroscience Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 26, 2025
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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