Inclusion Criteria:

• Is a male or female ≥ 30 years old at screening.
• Is considered to be “clinically possible” or “clinically probable” MSA as determined by the Gilman criteria (Gilman et al 2008).
• Is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive devices (eg, walker or cane) is allowed.
• If patient is receiving treatment for symptomatic MSA prior to randomization, therapy regimen must have been stable for a period of ≥ 28 days with no foreseeable changes predicted during the study including but not limited to:
  • Drugs acting against parkinsonism (eg, levodopa, dopamine-agonists, amantadine, and monoamine oxidase-B inhibitors);
  • Drugs acting against autonomic dysfunction (eg, ephedrine, midodrine, fludrocortisone, octreotide, desmopressin, and oxybutynine);
  • Antidepressant drugs (eg, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors).
• Is able to swallow the IMP, as determined by a dysphagia evaluation during the screening period and in follow-up evaluations during the course of the study; and is willing to swallow the IMP capsules whole, and as scheduled, throughout the duration of the study.
• Is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination.
• In the investigator’s opinion, the patient and/or patient’s caregiver(s) has (have) the ability to understand the nature of the study and its procedures, and is (are) able and willing to comply with the requirements of the study.
• If patient is personally unable to provide informed consent, a legally acceptable representative would provide written informed consent. The process for consent should follow the local regulatory requirements for those patients who cannot provide written informed consent. Caregiver consent will also be obtained in the circumstances where caregiver participation is applicable.
• Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits.
• Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods beginning 28 days before the first administration of IMP, the duration of the study, and 28 days after the last dose of IMP (see Appendix D).
• Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods for the duration of the study and for 28 days after the last dose of IMP (see Appendix D).

Exclusion Criteria: 

• Has any clinically significant uncontrolled medical or psychiatric condition (treated or untreated), other than MSA that, in the opinion of the investigator, could jeopardize or would compromise the patient’s ability to participate in any study assessments.
• Severely affected with a UMSARS part IV score of 5.
• Is suspected of having a neurodegenerative disease other than MSA, in the opinion of the investigator.
• Has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA.
• Has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening, or has previously participated in other studies of neuroprotective therapies (eg, deferiprone, exenatide, or alpha-synuclein antibodies or vaccinations, anti-sense oligonucleotides); the investigator should consult with the medical monitor or study physician/study clinical leader as needed.
• Has a history of an intracranial or intraspinal space occupying lesion, increased intracranial pressure, or any other known condition in the medical history that, according to the investigator’s judgment, may preclude the patient from the procedure of cerebrospinal fluid (CSF) sampling.
• Has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening.
• Is a female patient who is pregnant or breastfeeding, or plans to become pregnant during the study.
• Is diagnosed with concurrent severe depression defined by a score ≥ 30 on the Beck Depression Inventory-II and/or has a significant risk of committing suicide based on the patient’s medical history or investigator’s judgement and/or the C-SSRS (lifetime); patients with a C-SSRS (current) positive response to suicidal ideation items 3, 4, or 5 are not eligible.
• Has a known hypersensitivity to any components of the IMP.
• Has moderate to severe renal impairment as assessed by estimated glomerular filtration rate < 60 mL/min l. has moderate to severe hepatic impairment as assessed by Child-Pugh Score of 7 or above 37.
• Has any clinically significant disorder that may interfere with absorption, distribution, metabolism, or excretion of IMPs (including relevant gastrointestinal surgery, malabsorption syndrome) that in the opinion of the investigator makes the patient unsuitable for the trial.
• Is of a vulnerable population (eg, people kept in detention).
• Patient is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study (see Appendix F).

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

Eligibility last updated 1/3/24. Questions regarding updates should be directed to the study team contact.