A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy
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 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