Phase III Study of NIO752 for Treating Progressive Supranuclear Palsy Richardson Syndrome in Adults Aged 41 to 81

What this Trial Is About

Researchers are evaluating the efficacy and safety of NIO752 in adults aged 41 to 81 with Progressive Supranuclear Palsy Richardson Syndrome PSP-RS, a rare neurological disorder. This Phase III randomized, double-blind, placebo-controlled study compares NIO752 to a placebo in participants with mild to moderate PSP, with symptoms starting less than five years ago. The study is sponsored by Novartis Pharmaceuticals and includes an open-label extension after the initial treatment period. Participants will be randomly assigned in a 21 ratio to receive either NIO752 solution or a placebo solution. After completing the double-blind treatment phase, all participants will have the option to continue receiving NIO752 in an open-label extension. The study monitors changes over 72 weeks, with various assessments including brain imaging and biomarker analysis. During the study, participants and their reliable study partners will attend regular visits for evaluations such as cognitive testing, daily living activities, and safety monitoring. Researchers will measure changes from baseline in PSP rating scales and other neurological functions. Safety will be assessed by tracking adverse events, and the total participation may last up to several years including the open-label extension.

A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy