A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy (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)
- EU CT Number
- 2023-505320-54-00
- Study Description
- Primary objectives: 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). Secondary objectives: 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.
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Adult, Older Adult
- Age Range
- 30 years to 75 years
- Trial Duration
- October 02, 2024 – September 15, 2027
- Phase
- Phase 2