A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy
ConditionMultiple System Atrophy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30+
SponsorDasher Neuroscience Inc.
About 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.
Eligibility criteria
Qualifiers
Able to understand the process of the clinical trial and give informed consent for the participation of the study.
Diagnosis of MSA according to MDS clinical criteria (Wenning et al, 2022), including subjects with MSA of either subtype (MSA-P or MSA-C).
Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
Able to take oral medications.
Disqualifiers
Positive urine test for drugs of abuse and/or alcohol test both at screening and Day 1.
Evidence of renal impairment or hepatic impairment.
Subject with a Mini-Mental State Examination (MMSE) score of 24 or lower.
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.
Trial design
Treatments tested in this trial
- YA-101
- Placebo
Treatment groups
75 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov