CNIO752A12301: NIO752 in participants with Progressive Supranuclear palsy
Research type
Research Study
Full title
A Phase III, randomized, placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy followed by an Open Label Extension
IRAS ID
1012744
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Eudract number
2025-523481-24
Clinicaltrials.gov Identifier
Research summary
CNIO752A12301 is a phase III trial, designed to evaluate the effects of NIO752 in individuals diagnosed with Progressive Supranuclear Palsy (PSP), a serious disease of the brain that causes difficulties with balance, walking, eye movements, speech, and thinking. NIO752 is a trial drug that may slow down the worsening of PSP symptoms. The study involves 300 participants aged between 41 to 81 years, diagnosed with PSP within the last five years, who can walk at least ten steps independently or with minimal assistance and do not have another brain disease, or psychiatric illness. The trial will have two periods. During period one, participants will randomly receive either NIO752 or Placebo. None of the participants, trial doctors, or trial staff will know which treatment the participants will receive. All participants who complete the first period, if eligible, can enter Period 2 where they all receive NIO752. Trial doctors, trial staff and participants will know which treatment the participants will receive during Period 2. Researchers will rate symptoms using clinical rating scales to evaluate changes in daily functioning, quality of life and cognitive abilities. Participants will have magnetic resonance imaging brain scans to see whether different brain regions shrink or lose volume over time. Results from previous trials indicate that NIO752 may benefit people with PSP and for this trial it may help in developing newer treatment options. There might be medical problems with NIO752 that are not yet known or have not been predicted. Participants will be closely monitored by the trial doctors for any such medical problems that may happen during the study. Once the study is complete, results will be shared in clear, easy-to-understand language with participants and the public.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
26/EM/0040
Date of REC Opinion
25 Mar 2026
REC opinion
Further Information Favourable Opinion