YA-101 for Multiple System Atrophy

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yoda Therapeutics Inc.

Disqualifiers: Renal impairment, Hepatic impairment, Uncontrolled diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

42 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for individuals with multiple system atrophy, a progressive neurological disorder. Participants should meet specific health criteria set by the study and not have conditions that could interfere with the trial.

Inclusion Criteria

I can take pills by mouth.

I understand the clinical trial process and can consent to participate.

I have been diagnosed with MSA according to specific clinical criteria.

Exclusion Criteria

I have kidney or liver problems.

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

Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive YA-101 or placebo to evaluate safety, tolerability, pharmacokinetics, and efficacy

8 weeks

Regular visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• YA-101

Trial Overview The study tests YA-101 against a placebo to see if it's safe and effective for treating multiple system atrophy. It's double-blind, meaning neither participants nor researchers know who gets the real drug or placebo.

Participant Groups

Group I: YA-101 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Yoda Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

40+