Multiple System Atrophy
Conditions
Brief summary
The primary efficacy endpoint (TEV-56286 versus placebo, change from baseline to week 48) is as follows: • modified UMSARS part I (excluding item 11, item scoring rescaled 0-3)
Detailed description
The Secondary efficacy endpoints (TEV-56286 versus placebo, change from baseline to week 48) are as follows: • total UMSARS score (part I and part II combined) • UMSARS part I score • CGI-S • MSA-QoL, Safety endpoints include the following: 1. number (%) of participants per adverse events, Safety endpoints include the following: 2. number (%) of patients who withdraw from the study due to an adverse event, Safety endpoints include the following: 4. number (%) of patients with potentially clinically significant vital sign values, Safety endpoints include the following: 5. number (%) of patients with potentially clinically significant laboratory test values (hematology and chemistry), Safety endpoints include the following: 6. number (%) of patients with potentially clinically significant changes in 12-lead ECG measurements, Safety endpoints include the following: 3.number (%) of patients who withdraw from treatment due to an adverse event
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint (TEV-56286 versus placebo, change from baseline to week 48) is as follows: • modified UMSARS part I (excluding item 11, item scoring rescaled 0-3) | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary efficacy endpoints (TEV-56286 versus placebo, change from baseline to week 48) are as follows: • total UMSARS score (part I and part II combined) • UMSARS part I score • CGI-S • MSA-QoL, Safety endpoints include the following: 1. number (%) of participants per adverse events, Safety endpoints include the following: 2. number (%) of patients who withdraw from the study due to an adverse event, Safety endpoints include the following: 4. number (%) of patients with potentially clinically significant vital sign values, Safety endpoints include the following: 5. number (%) of patients with potentially clinically significant laboratory test values (hematology and chemistry), Safety endpoints include the following: 6. number (%) of patients with potentially clinically significant changes in 12-lead ECG measurements, Safety endpoints include the following: 3.number (%) of patients who withdraw from treatment due to an adverse event | — |
Countries
France, Germany, Italy, Spain