FNP-223 for Progressive Supranuclear Palsy
Recruiting in Palo Alto (17 mi)
+35 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Ferrer Internacional S.A.
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What makes the drug FNP-223 unique for treating Progressive Supranuclear Palsy?
The drug FNP-223 is unique because it targets tau-protein aggregates, which are closely associated with neurodegeneration in Progressive Supranuclear Palsy, a condition with no standard treatments. This approach is different from other treatments that have failed to show efficacy in clinical trials.
12345Eligibility Criteria
This trial is for individuals aged 50-80 with Progressive Supranuclear Palsy (PSP), who've had symptoms like difficulty moving their eyes or frequent falls within the first three years of onset. They should weigh between 95 and 265 lbs, be able to walk at least ten steps with minimal help, not live in a nursing facility, and have a caregiver.Inclusion Criteria
Presence of PSP symptoms ≤3 years
My weight is between 95 and 265 lbs.
I can walk on my own or with a cane.
I am between 50 and 80 years old.
Exclusion Criteria
I do not have PSP-RS movement disorders or other CNS diseases.
I have a known genetic mutation based on my family or medical history.
My recent brain MRI shows a condition that is not PSP.
Participant Groups
The PROSPER trial is testing FNP-223's ability to slow down PSP progression compared to a placebo. Participants will be evaluated using the PSP Rating Scale over one year while also monitoring the safety and effects of FNP-223 on their bodies.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FNP-223Experimental Treatment1 Intervention
Participants will receive FNP-223 orally (PO), 3 times daily (TID).
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo, PO, TID.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
Massachusetts General HospitalBoston, MA
Robert & John M. Bendheim Parkinson and Movement Disorders Center at Mount SinaiNew York, NY
UCSF Weill Institute for NeurosciencesSan Francisco, CA
More Trial Locations
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Who is running the clinical trial?
Ferrer Internacional S.A.Lead Sponsor
References
The Added Value of Tau-PET in the Assessment of Progressive Supranuclear Palsy. [2021]Progressive supranuclear palsy (PSP) is rare neurodegenerative disorder characterized by deposition of fibrillar aggregates of 4R tau-protein in neurons and glial cells. This disorder is underdiagnosed due to the overlap of the clinical syndrome with other related conditions. The clinical manifestations include cognitive impairment associated with behavioral changes, akinetic rigid syndrome, and prominent oculomotor dysfunction. We present the F-FDG and F-THK5351 PET images of a 71-year-old man diagnosed of probable PSP. This image highlights the hopeful results of the new tau-PET ligands radiotracers, because it allows to assess the distribution of tau-protein over time, closely associated with neurodegeneration in PSP.
PET imaging of neuropathology in tauopathies: progressive supranuclear palsy. [2021]Currently [18F]FDDNP is the only PET imaging probe with the ability to visualize hyperphosphorylated tau fibrillar aggregates in living subjects. In this work, we evaluate in vivo [18F]FDDNP labeling of brain neuropathology, primarily tau fibrillar aggregates, in patients with progressive supranuclear palsy (PSP), a human tauopathy usually lacking amyloid-β deposits.
18F-THK5351 PET imaging in patients with progressive supranuclear palsy: associations with core domains and diagnostic certainty. [2021]The associations of 18F-THK5351 tau positron emission tomography (PET) findings with core domains of progressive supranuclear palsy (PSP) and its diagnostic certainty have yet to be fully elucidated. The 18F-THK5351 PET patterns of 17 patients with PSP (68.9 ± 6.5 years; 8 women) were compared with those observed in 28 age-matched and sex-matched (66.2 ± 4.5 years, 18 women) control subjects (CS). Tracer accumulation-as reflected by standardized uptake value ratios (SUVRs) and z-scores-was correlated with core domains of PSP and different levels of diagnostic certainty. Compared with CS, patients with PSP showed an increased 18F-THK5351 uptake in the globus pallidus and red nucleus. Patients with PSP and oculomotor dysfunction had significantly higher SUVRs in the midbrain, red nucleus, and raphe nucleus than those without. In addition, cases who meet criteria for level 1 (highest) certainty in the postural instability domain showed significantly higher SUVRs in the frontal, parietal, precuneus, and sensory-motor cortex. Patients with probable PSP had significantly higher SUVR values than those with possible PSP in multiple cortical (i.e., frontal, parietal, temporal, anterior cingulate gyrus, precuneus, and sensory-motor gyrus) and subcortical (i.e., putamen, thalamus, and raphe nucleus) regions. Patterns of 18F-THK5351 uptake were correlated to core domains of PSP-including oculomotor dysfunction and postural instability. Moreover, the degree of diagnostic certainty for PSP was appreciably associated with 18F-THK5351 PET findings.
Clinical Features of Patients With Progressive Supranuclear Palsy in an US Insurance Claims Database. [2021]Background: Progressive supranuclear palsy is a rare neurodegenerative movement disorder and little is known about its epidemiology. Objective: Estimate age-adjusted prevalence of progressive supranuclear palsy and describe antecedent diagnoses and progressive supranuclear palsy patient features in the 5 years before first diagnostic code. Methods: In a nested case-control study in the IBM MarketScan Commercial and Medicare Supplemental Databases, a large set of US insurance databases containing medical service and prescription drug claims from employer-based commercial and Medicare supplemental health insurance plans, progressive supranuclear palsy cases (identified via International Statistical Classification of Diseases 9th/10th revision codes) and controls were included if enrollment was ≥1 month in the study period (October 1, 2015-October 31, 2017). Two controls with no diagnosis codes for PSP were matched to cases on birth year, sex, enrollment time in the database, and pharmacy benefit eligibility. Controls were assigned a randomly selected index date from their eligibility period. Prevalence of progressive supranuclear palsy was estimated in 2016 among patients with ≥1 month of continuous enrollment in that year. Prevalence ratios for comorbidities (claim/diagnosis codes) were examined in the ≤ 5 years before index date (first progressive supranuclear palsy claim date). Results: Age-adjusted progressive supranuclear palsy prevalence was 2.95/100,000 in 2016. The most common diagnosis codes in cases vs. controls in the 5 years pre-index were gait abnormalities (79.3 vs. 21.8%), pain in joint (54.9 vs. 36.0%), Parkinson's disease (54.6 vs. 1.0%), fatigue (49.8 vs. 21.6%), and cerebrovascular disease (45.6 vs. 16.4%). Conclusions: In this large database analysis, based on preliminary analyses, the prevalence of diagnosed progressive supranuclear palsy was 2.95/100,000, which is lower than many prior studies. Typical symptoms suggestive of progressive supranuclear palsy were present before index date, indicating a potential delay in time to diagnosis. The identification of diagnostic codes for clinical features of progressive supranuclear palsy that occurred before index date may be used to develop predictive models to identify potential progressive supranuclear palsy patients earlier in their disease course.
Power calculations and placebo effect for future clinical trials in progressive supranuclear palsy. [2021]Two recent randomized, placebo-controlled trials of putative disease-modifying agents (davunetide, tideglusib) in progressive supranuclear palsy (PSP) failed to show efficacy, but generated data relevant for future trials.