NCT06355531进行中（未招募）2 期
A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 (Oral Formulation) to Slow the Disease Progression of Progressive Supranuclear Palsy (PSP) (PROSPER)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 241
- 试验地点
- 44
- 主要终点
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
PROSPER trial is a trial to assess the efficacy of FNP-223 in slowing disease progression in participants with PSP as measured by the PSP Rating Scale (PSPRS) over 52 weeks and to assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 50 to 80 years, inclusive, at the time of informed consent.
- •Diagnosis of possible or probable PSP of the Richardson's Syndrome (PSP-RS) phenotypes according to the Movement Disorders Society's Progressive Supranuclear Palsy (MDS PSP) clinical features criteria. At least 1 (either 1 or both) of the following 2 items must be met:
- •Vertical supranuclear gaze palsy.
- •Slowing of vertical saccades AND postural instability with falls within the first 3 years of PSP symptoms.
- •Presence of PSP symptoms within ≤3 years prior to screening.
- •MoCA score ≥23
- •Full 28-item PSPRS score ≤
- •Able to ambulate independently or with minimal assistance defined as the ability to take at least 10 steps (stabilization of 1 arm [ie, use of cane]).
- •Body weight range ≥43 kg/95 lbs to ≤120 kg/265 lbs.
- •Reside outside a skilled nursing facility or dementia care facility, except for participants residing in an assisted living facility.
- •Has a caregiver or study partner who will accompany them to the study visits. The caregiver or study partner must be a person who has frequent contact (at least 7 hours per week at 1 time or in different days) with the participant and is able to provide information about the participant's medication and overall condition. Prior to the conduct of any study procedures, the caregiver or study partner must be willing to sign the independent ethics committee (IEC)/institutional review board (IRB) approved informed consent.
排除标准
- •Non-PSP- RS Movement Disorders or other central nervous system (CNS) Diseases
- •Score of 3 on any functional domain in the PSP-CDS.
- •Participants with known PSP genetic mutation (based on familiar or clinical history).
- •Evidence of other neurological disorder that could explain signs of PSP (eg, Parkinson's disease, Alzheimer disease, etc.).
- •Brain magnetic resonance imaging (MRI) within 1 year of screening consistent with:
- •Primary degenerative diseases other than PSP.
- •For the optional substudy only: Contraindication or refusal to undergo 2 lumbar punctures for obtaining CSF.
- •Contraindication or inability to tolerate MRI for screening MRI and volumetric brain MRI assessments throughout the substudy.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive matching placebo, PO, TID.
干预措施: Placebo (Drug)
FNP-223
Experimental
Participants will receive FNP-223 orally (PO), 3 times daily (TID).
干预措施: FNP-223 (Drug)
结局指标
主要结局
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
时间窗: Baseline to Week 52
Clinically significant changes in vital signs, clinical laboratory evaluations, physical examinations, and electrocardiogram (ECG) are included in TEAEs.
Number of Participants Experiencing Serious Adverse Events (SAEs)
时间窗: Baseline to Week 52
Change From Baseline to Week 52 in the PSPRS Outcome
时间窗: Baseline to Week 52
次要结局
- Change From Baseline to Week 52 in Caregiver Global Impression of Severity Scale (CaGI-S)(Baseline to Week 52)
- Change From Baseline to Week 52 in Clinical Global Impression of Severity Scale (CGI-S)(Baseline to Week 52)
- Change From Baseline to Week 52 Participant Global Impression of Severity Scale (PGI-S)(Baseline to Week 52)
- Slope of Decline in PSPRS(Baseline to Week 52)
- Change From Baseline to Week 52 in PSP Quality of Life Scale (PSP-QoL)(Baseline to Week 52)
- Pharmacokinetic characterization of FNP-223(At Week 4 and Week 16)
- Change From Baseline to Week 52 in Individual Subitems of PSPRS(Baseline to Week 52)
- Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale(Baseline to Week 52)
- Change From Baseline to Week 52 in PSP Clinical Deficits Scale (PSP-CDS)(Baseline to Week 52)
- Change From Baseline to Week 52 in Montreal Cognitive Assessment (MoCA)(Baseline to Week 52)
研究者
研究点 (44)
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