Language: BG BG
← Back to results
Recruiting Phase 3 2025-523481-24-00

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

Phase 3 – large-scale trial before approval
Conditions: Participants with Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)

Sponsor: Novartis Pharma AG

trial.available_in: БГ
Overview
Trial status: Authorised Change from baseline at Week 72 in the PSPRS-28, Changes from baseline at Week 72 in activities of daily living on the XXX, Change from baseline at Week 72 in the Progressive Supranuclear Palsy Quality of Life scale (PSP-ShoQoL), Change from baseline at Week 72 in the Category Fluency, Phonemic Fluency, Symbol Digit Modality Test (SDMT), and Letter-Number- Sequencing (LNS), Changes from baseline in volumes of ventricles, whole brain, midbrain, pons, superior cerebellar peduncle, third ventricle, frontal lobe as measured by MRI until Week 72., Safety and tolerability parameters including AEs, AESIs, SAEs (including SAEs with fatal outcomes), AEs leading to XXX and treatment interruptions, AEs leading to dose discontinuation, clinical laboratory evaluations, vital signs, electrocardiogram (ECG), XXX Change from baseline at Week 72 in the rPSPRS-10 score
Description
Change from baseline at Week 72 in the PSPRS-28, Changes from baseline at Week 72 in activities of daily living on the XXX, Change from baseline at Week 72 in the Progressive Supranuclear Palsy Quality of Life scale (PSP-ShoQoL), Change from baseline at Week 72 in the Category Fluency, Phonemic Fluency, Symbol Digit Modality Test (SDMT), and Letter-Number- Sequencing (LNS), Changes from baseline in volumes of ventricles, whole brain, midbrain, pons, superior cerebellar peduncle, third ventricle, frontal lobe as measured by MRI until Week 72., Safety and tolerability parameters including AEs, AESIs, SAEs (including SAEs with fatal outcomes), AEs leading to XXX and treatment interruptions, AEs leading to dose discontinuation, clinical laboratory evaluations, vital signs, electrocardiogram (ECG), XXX
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 56 participants
Interventions
NIO752
Drug
Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung
Drug
Locations 3
Belgium (1)
Germany (1)
Netherlands (1)
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
21.04.2026
Registry ID
2025-523481-24-00
Source
euclinicaltrials.eu
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.