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
Teva Branded Pharmaceutical Products R&D LLC
Lead sponsor