Actively Recruiting

Phase 3
Age: 41Years - 81Years
All Genders
NCT07498426

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

Led by Novartis Pharmaceuticals · Updated on 2026-05-12

300

Participants Needed

2

Research Sites

268 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 41Years - 81Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent obtained before participation
  • Male or female aged between 41 and 81 years inclusive
  • Diagnosed with mild to moderate probable or possible PSP Richardson syndrome with symptoms starting less than 5 years ago
  • PSPRS total score less than 40 at baseline
  • Have a reliable study partner spending at least 5 hours per week with you, able to provide accurate information and participate in study visits
  • Able to walk at least 10 steps independently or with minimal assistance
  • Mini Mental State Examination (MMSE) score of 20 or higher at screening
Not Eligible

You will not qualify if you...

  • Diagnosis of other significant neurological or psychiatric disorders such as Parkinson's Disease not revised to PSP, Alzheimer's disease, dementia with Lewy bodies, prion disease, psychotic disorders, severe major depressive disorder, seizure, brain tumor, or history of significant stroke
  • Diagnosis of amyotrophic lateral sclerosis or other motor neuron diseases
  • Diagnosis of cerebellar ataxia, choreoathetosis, or early symptomatic autonomic dysfunction
  • History or MRI scan showing significant brain abnormalities including hemorrhage, infarcts, contusions, aneurysm, vascular malformations, subdural hematoma, hydrocephalus, or space-occupying lesions
  • Contraindications to MRI such as metal implants or incompatible cardiac pacemaker
  • Medical conditions preventing lumbar puncture including allergy to local anesthetic, history of certain back surgeries, spinal deformities, skin infections at lumbar puncture site, or bleeding risks
  • History of deep brain stimulator surgery other than sham surgery for clinical trial participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

CenExcel Rocky Mtn Clin Research

Englewood, Colorado, United States, 80113

Actively Recruiting

2

Novartis Investigative Site

Ulm, Germany, 89081

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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