A Phase 2 Study of YA-101 in Patients with Multiple System Atrophy

Launched by YODA THERAPEUTICS INC. · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called YA-101 for people with Multiple System Atrophy (MSA), a rare and progressive neurological condition affecting movement and coordination. The trial is in its second phase, meaning researchers are looking to find out how safe the treatment is, how well it works, and how the body processes it. The study will compare YA-101 to a placebo, which is a substance with no active medication, to see if it has a real effect. The trial is not yet recruiting participants.

To be eligible for the trial, participants must have a confirmed diagnosis of MSA and be able to understand the study and provide consent. They should be able to take oral medications and move around independently. Additionally, they should not have certain serious health issues, like severe liver or kidney problems, and must not have a history of substance abuse. Those who qualify will be part of a carefully monitored study that aims to improve the understanding and treatment of MSA, and they will be contributing to advancements in care for this challenging condition.

Gender

ALL

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.