Actively Recruiting
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
Eligibility Criteria
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
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
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
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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