RECRUITING

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

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Conditions

Multiple System Atrophy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-03-03
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06848231

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.

Ages Eligible for Study:30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to understand the process of the clinical trial and give informed consent for the participation of the study.
  2. 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. 3. Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
  4. 4. Able to take oral medications.
  5. 5. Able to ambulate without the assistance of another person.
  1. 1. Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1.
  2. 2. Evidence of renal impairment or hepatic impairment.
  3. 3. Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower.
  4. 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. 5. Positive results for active viral infections, including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.

Contacts and Locations

Study Contact

Email contact via Yoda Therapeutics Inc.
CONTACT
857-468-9328
info@yodapharma.com

Study Locations (Sites)

UCLA Health
Los Angeles, California, 90095
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Columbia University Irving medical center
New York, New York, 10032
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Yoda Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-03-03
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple System Atrophy