2025-523481-24-00招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 41
- 主要终点
- Change from baseline at Week 72 in the rPSPRS-10 score
研究概览
简要总结
To evaluate the efficacy of NIO752 compared to placebo on disease progression using rPSPRS-10 at week 72
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NIO752
Test
干预措施: NIO752 (Drug)
Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung
Placebo
干预措施: Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung (Drug)
结局指标
主要结局
Change from baseline at Week 72 in the rPSPRS-10 score
Change from baseline at Week 72 in the rPSPRS-10 score
次要结局
- 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
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (41)
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