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

Study Title
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
Teva Identifier
TV56286-NDG-20039
ClinicalTrials.gov Identifier
NCT06568237
Study Status
Recruiting
Trial Condition(s)
Multiple System Atrophy
Interventions
Drug: TEV-56286 (emrusolmin, anle138b)
EudraCT Number
2023-505320-54-00

Study Description

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.
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Key Participation Requirements

Gender
Female, Male
Age Range
30 Years and older
Trial Duration
October 02, 2024 - June 17, 2027
Phase
Phase 2

Study Type

Interventional