Summary

Eligibility
for people ages 30 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

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

Details

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.

Keywords

Multiple System Atrophy, Shy-Drager Syndrome, Atrophy

Eligibility

You can join if…

Open to people ages 30 years and up

  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.

You CAN'T join if...

  1. Positive urine test for drugs of abuse and/or alcohol test both at screening and Day
  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.

Locations

  • UCLA Health
    Los Angeles California 90095 United States
  • Baylor College of Medicine
    Houston Texas 77030 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Yoda Therapeutics Inc.
ID
NCT06848231
Phase
Phase 2 Multiple System Atrophy Research Study
Study Type
Interventional
Participants
Expecting 42 study participants
Last Updated