A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy
Start Date
6/3/2026
Completion Date
7/18/2031
Summary
This Phase III study is intended to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy (PSP). Eligible participants will be randomized to receive either NIO752 or placebo followed by an open-label extension.
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel group, study to evaluate the efficacy of NIO752 in participants with Progressive Supranuclear Palsy followed by an open-label extension (OLE). The participants with or without symptomatic therapy will be randomly allocated to either NIO752 or placebo treatment in a 2:1 randomization ratio. Upon completion of the core double-blind treatment period, participants will be offered to continue with NIO752 treatment in the OLE.
Eligibility Criteria
Age Range: 41 years to 81 years
Interventions
NIO752
Placebo
Conditions
Locations
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United States
Univ of California San Francisco
San Francisco, California 94158
United States
CenExcel Rocky Mtn Clin Research
Englewood, Colorado 80113
United States
Mayo Jacksonville
Jacksonville, Florida 32224
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Novartis Investigative Site
Westmead, New South Wales 2145
Australia
Novartis Investigative Site
Melbourne, Victoria 3004
Australia
Novartis Investigative Site
Shanghai, 200040
China
Novartis Investigative Site
Suzhou, 215000
China
Novartis Investigative Site
Caen, 14033
France
Novartis Investigative Site
Créteil, 94010
France
Novartis Investigative Site
Lille, 59037
France
Novartis Investigative Site
Marseille, 13885
France
Novartis Investigative Site
Nantes, 44093
France
Novartis Investigative Site
Paris, 75013
France
Novartis Investigative Site
Rennes, 35033
France
Novartis Investigative Site
Toulouse, 31059
France
Novartis Investigative Site
Munich, Bavaria 81377
Germany
Novartis Investigative Site
Würzburg, Bavaria 97080
Germany
Novartis Investigative Site
Bonn, North Rhine-Westphalia 53127
Germany
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia 40225
Germany
Novartis Investigative Site
Dresden, Saxony 01307
Germany
Novartis Investigative Site
Leipzig, Saxony 04103
Germany
Novartis Investigative Site
Beelitz, 14547
Germany
Novartis Investigative Site
Berlin, 13353
Germany
Novartis Investigative Site
Stadtroda, 07646
Germany
Novartis Investigative Site
Tübingen, 72076
Germany
Klinik für Neurologie (Schwerpunkt Neurodegeneration)
Ulm, 89081
Germany
Novartis Investigative Site
Milan, MI 20133
Italy
Novartis Investigative Site
Roma, RM 00168
Italy
Novartis Investigative Site
Kodaira, Tokyo 187-8551
Japan
Novartis Investigative Site
Rotterdam, South Holland 3015 GD
Netherlands
Novartis Investigative Site
Nijmegen, 6525 GA
Netherlands
Novartis Investigative Site
Seoul, 03722
South Korea
Novartis Investigative Site
Pozuelo de Alarcón, Madrid 28223
Spain
Novartis Investigative Site
Barcelona, 08036
Spain
Novartis Investigative Site
Barcelona, 08041
Spain
Novartis Investigative Site
Las Palmas GC, 35010
Spain
Novartis Investigative Site
Madrid, 28009
Spain
Novartis Investigative Site
Madrid, 28034
Spain
Novartis Investigative Site
Madrid, 28041
Spain
Novartis Investigative Site
Seville, 41013
Spain