The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).

A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286.

Another secondary objective is to evaluate the safety and tolerability of TEV-56286.

The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.

We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, Japan, and Serbia.

Inclusion Criteria:

• is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria

• 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

Exclusion Criteria:

• 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

Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.