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.
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
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
Parallel
TEV-56286
DrugTEV-56286 capsules administered orally
Placebo
DrugMatching placebo administered orally
For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11)
The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Modified UMSARS part I includes all items with the exclusion of item 11. Item scoring is scaled 0-3 using a range of 0 (no impairment) to 3 (severe impairment).
For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined
The UMSARS is comprised of 4 parts: part I, historical review of disease-related impairments, 12 items and part II, motor examination, 14 items. As UMSARS is a unified scale, each item in parts I and II achieves a single score using a range of 0 (no impairment) to 4 (severe impairment).
For non-EU: Change From Baseline in the Total UMSARS Score (Part I and Part II combined)
For EU: Change From Baseline in the Modified UMSARS part I score (excluding item 11, item scoring rescaled 0-3)
Change From Baseline in the UMSARS Part 1 Score
Change From Baseline in Lateral Ventricle Volume Measured by MRI
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