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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
EU CTIS ID: 2025-523481-24-00
What this study is testing
To evaluate the efficacy of NIO752 compared to placebo on disease progression using rPSPRS-10 at week 72
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent must be obtained prior to participation in the study.
- Male or female participants, age between 41-81 years old inclusive.
- Diagnosis of mild-moderate, probable/possible PSP Richardson syndrome as per MDS- PSP 2017 criteria with symptoms onset < 5 years
- PSPRS total score less than 40 at Baseline
- Reliable study partner such as spouse, sibling, close friend, or caregiver able and willing to provide accurate information (including clinical symptoms and medical history) about the participant and to participate in study visits and informant-based assessments for the duration of the study. A reliable study partner is expected to spend enough time (at least 5 hours per week) with the study participant
- Participant is able to ambulate defined as the ability to take at least 10 steps independently or with minimal assistance (stabilization of one arm to minimize fall risk)
You likely can't join if
- Diagnosis of other significant neurological or psychiatric disorders including (but not limited to) Parkinsons’ Disease (which has not subsequently been revised to a diagnosis of PSP); Alzheimer’s disease (AD), dementia with Lewy bodies; prion disease; any psychotic disorders; severe Major depressive disorder; seizure; brain tumor or other space- occupying lesion; history of clinically significant stroke (e.g., stroke with permanent neurological deficit); history of head injury with loss of consciousness for at least 15 minutes within the past 20 years.
- Diagnosis of amyotrophic lateral sclerosis or other motor neuron diseases.
- Diagnosis of cerebellar ataxia, choreoathetosis, and early symptomatic autonomic dysfunction.
- History of or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct >1 cm diameter, >3 lacunar infarcts, cerebral contusion, aneurysm, vascular malformation >1 cm diameter, subdural hematoma, hydrocephalus, and space-occupying lesion (e.g., abscess or brain tumor).
- Contraindications to undergo MRI procedure, including metal (ferromagnetic) implants and/or a cardiac pacemaker that is not compatible with MRI.
- History of deep brain stimulator surgery other than sham surgery for participation in a deep brain stimulation clinical trial.
See the full eligibility criteria
Who can join
- Signed informed consent must be obtained prior to participation in the study.
- Male or female participants, age between 41-81 years old inclusive.
- Diagnosis of mild-moderate, probable/possible PSP Richardson syndrome as per MDS- PSP 2017 criteria with symptoms onset < 5 years
- PSPRS total score less than 40 at Baseline
- Reliable study partner such as spouse, sibling, close friend, or caregiver able and willing to provide accurate information (including clinical symptoms and medical history) about the participant and to participate in study visits and informant-based assessments for the duration of the study. A reliable study partner is expected to spend enough time (at least 5 hours per week) with the study participant
- Participant is able to ambulate defined as the ability to take at least 10 steps independently or with minimal assistance (stabilization of one arm to minimize fall risk)
- MMSE score ≥ 20 at Screening.
What rules you out
- Diagnosis of other significant neurological or psychiatric disorders including (but not limited to) Parkinsons’ Disease (which has not subsequently been revised to a diagnosis of PSP); Alzheimer’s disease (AD), dementia with Lewy bodies; prion disease; any psychotic disorders; severe Major depressive disorder; seizure; brain tumor or other space- occupying lesion; history of clinically significant stroke (e.g., stroke with permanent neurological deficit); history of head injury with loss of consciousness for at least 15 minutes within the past 20 years.
- Diagnosis of amyotrophic lateral sclerosis or other motor neuron diseases.
- Diagnosis of cerebellar ataxia, choreoathetosis, and early symptomatic autonomic dysfunction.
- History of or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct >1 cm diameter, >3 lacunar infarcts, cerebral contusion, aneurysm, vascular malformation >1 cm diameter, subdural hematoma, hydrocephalus, and space-occupying lesion (e.g., abscess or brain tumor).
- Contraindications to undergo MRI procedure, including metal (ferromagnetic) implants and/or a cardiac pacemaker that is not compatible with MRI.
- History of deep brain stimulator surgery other than sham surgery for participation in a deep brain stimulation clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Japan
- United States
- United Kingdom
- Canada
- Australia
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Japan; United States; United Kingdom; Canada; Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.