A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy (MSA): A Safety and Efficacy Study

Open to people ages 30 years and up

• is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria
• is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive device (eg, cane, not walker) is allowed
• is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination
• 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
• 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
  • Additional criteria apply; please contact the investigator for more information

• 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
• has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening
• is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study
• has a known hypersensitivity to any components of the IMP
• is of a vulnerable population (eg, people kept in detention or jail)
• participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study
  • Additional criteria apply; please contact the investigator for more information