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

Condition(s) studied

Investigational drug(s) / intervention(s)

TEV-56286: TEV-56286 capsules administered orally

Placebo: Matching placebo administered orally

Study 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.

Eligibility

Primary outcome measure(s)

• For non-EU: Change From Baseline in the Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (excluding item 11) — Baseline to Week 48
  The UMSARS is a multidimensional, validated scale for semi-quantitative clinical assessments of MSA participants. Modified UMSARS part I includes all items with the exclusion of item 11. Item scoring is scaled 0-3 using a range of 0 (no impairment) to 3 (severe impairment).
• For EU: Change From Baseline in the Total UMSARS Score Part I and Part II Combined — Baseline to Week 48
  The UMSARS is comprised of 4 parts: part I, historical review of disease-related impairments, 12 items and part II, motor examination, 14 items. As UMSARS is a unified scale, each item in parts I and II achieves a single score using a range of 0 (no impairment) to 4 (severe impairment).

Trial sites (68)

+ 28 more sites — see the full list on the official registry below.

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