Progressive Supranuclear Palsy
Conditions
Brief summary
Change from Baseline at Week 52 in the total PSPRS Score * *A primary endpoint—which meets evidentiary requirements of the United States of America (USA) and outside of the USA, respectively—was selected as follows: change from baseline in the 10-item PSPRS at Week 52 (for the USA) and change from baseline in the 28-item PSPRS at Week 52 (for outside of the USA). For each region, only the endpoint which meets evidentiary requirements of that region is considered the primary endpoint; ...
Detailed description
Change from Baseline at Week 52 in the PSPRS Score * * Same as above, Change from Baseline at Week 52 in the MDS-UPDRS Part II Score., Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Interventions
DRUGPlacebo matching AMX0035
DRUGAMX0035
Sponsors
Amylyx Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline at Week 52 in the total PSPRS Score * *A primary endpoint—which meets evidentiary requirements of the United States of America (USA) and outside of the USA, respectively—was selected as follows: change from baseline in the 10-item PSPRS at Week 52 (for the USA) and change from baseline in the 28-item PSPRS at Week 52 (for outside of the USA). For each region, only the endpoint which meets evidentiary requirements of that region is considered the primary endpoint; ... | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline at Week 52 in the PSPRS Score * * Same as above, Change from Baseline at Week 52 in the MDS-UPDRS Part II Score., Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | — |
Countries
Austria, Belgium, Bulgaria, France, Germany, Italy, Netherlands, Poland, Spain, Sweden
Outcome results
None listed