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

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

30 Years

Maximum Age

75 Years

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