RECRUITING

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

Description

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.

Conditions

Multiple System Atrophy
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Related Conditions:

Multiple System Atrophy

Study Overview

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Study Details

Study 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.

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

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

Condition
Multiple System Atrophy
Intervention / Treatment

-

Contacts and Locations

Los Angeles

UCLA Health, Los Angeles, California, United States, 90095

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

New York

Columbia University Irving medical center, New York, New York, United States, 10032

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

30 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yoda Therapeutics Inc.,

Study Record Dates

2026-12-31