Clinical Trials

Inclusion Criteria:

• Subject is able and willing to give informed consent for the participation of the study, and able to understand the process of the clinical trial.
• Diagnosis of clinically probable or established multiple system atrophy (MSA) according to MDS clinical criteria (Wenning et al., 2022), including subjects with MSA of either subtype (MSA-P or MSA-C), as confirmed by the investigator. Structural MRI image taken within 6 months of the screening is acceptable.
• Subject must be aged ≥ 30 years at the time of providing informed consent.
• Males or non-pregnant, non-lactating females with no child-bearing potential, or agree to use 2 forms of contraception.
• Able to swallow oral suspension drugs.
• Able to ambulate without the assistance of another person, defined as ability to walk at least 10 meters. Use of assistive devices (e.g. walker or cane) is allowed.
• Consent to videography or motion-capturing of subject’s gait and audio via camera or other digital devices, data for recognition features. Subject’s identity or faces will be obscured.

Exclusion Criteria: 

• Subject who has received any investigational drug in a clinical trial, esomeprazole, or omeprazole, or dextromethorphan, or memantine, or amantadine, or any treatment with stem cell therapy or placenta (including human umbilical cord blood), within 30 days prior to Day 1 or 5 half-lives (whichever is longer) unless approved by the medical monitor.
• Positive urine test for drugs of abuse (except marijuana (Tetrahydrocannabinol, THC) and benzodiazepines (BZD)) and/or positive alcohol breath test both at screening and Day 1 with repeat testing as needed.
• Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of 1.5 mg/dl.
• Subjects with hepatic impairment, as indicated by the Child-Pugh method, at screening will be excluded, unless approved by the medical monitor.
• 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;severe head trauma.
• Contraindications for brain MRI scan.
• Any clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the study or might affect the results of the study.
• Subject who has a medical history of peptic ulcer in one year prior to screening.
• Subjects taking CYP3A4 strong inhibitors or inducers or sensitive index substrates, after discussing with the medical monitor. See Table 12-2 for list of CYP3A4 strong inhibitors.
• Positive results at Screening for active viral infections that include positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis B core antibody, and hepatitis C virus (HCV).
• Subjects taking strong inhibitors and inducers of CYP2C8, and strong inhibitors of the P-gp transporter after discussing with the medical monitor.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/12/2024. Questions regarding updates should be directed to the study team contact.