NCT06568237

A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy

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 (TOPAS-MSA)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, Japan, and Serbia.

Conditions

• Multiple System Atrophy

Interventions

Type	Name	Description
DRUG	TEV-56286	TEV-56286 capsules administered orally
DRUG	Placebo	Matching placebo administered orally

Timeline

• Start date: 2024-10-02
• Primary completion: 2027-09-15
• Completion: 2027-09-15
• First posted: 2024-08-23
• Last updated: 2026-04-17

Locations

54 sites across 7 countries: United States, France, Germany, Israel, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study