A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: YA-101, Placebo.
- Who it may be relevant to
- Registry conditions: Multiple System Atrophy. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Japan, Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug YA-101
Drug: YA-101 • YA-101 taken BID - Drug Placebo
Placebo taken BID
Primary outcome measures
- Incidence and severity of Adverse Events (AEs) [Time frame: Baseline to Day 112]
Secondary outcome measures (5)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- UCLA Health — Los Angeles
- Brigham and Women's Hospital — Boston
- Mayo Clinic — Rochester
- Columbia University Irving medical center — New York
- Vanderbilt University Medical Center — Nashville
- Baylor College of Medicine — Houston
Taiwan · 2 centers
- National Taiwan University Hospital — Taipei
- National Taiwan University Hospital Cancer Center — Taipei
Japan · 1 center
- Juntendo University Hospital — Tokyo
Identifiers
NCT: NCT06848231 · YA-101-201