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

Conditions

Participants with Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)

Brief summary

Change from baseline at Week 72 in the rPSPRS-10 score

Detailed 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

Related papers

No related papers found yet.

Interventions

DRUGNIO752

DRUGIsotone Kochsalz-Lösung 0

DRUG9 % Braun Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline at Week 72 in the rPSPRS-10 score	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Outcome results

None listed