FNP-223 for Progressive Supranuclear Palsy

Recruiting at 41 trial locations

Overseen By Lawrence Honig

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ferrer Internacional S.A.

Disqualifiers: Parkinson's, Alzheimer's, PSP mutation, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

220 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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.

Eligibility 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

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

Reside outside a skilled nursing facility or dementia care facility

My weight is between 95 and 265 lbs.

Exclusion Criteria

Score of 3 on any functional domain in the PSP-CDS

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FNP-223 or placebo orally, 3 times daily for 52 weeks

52 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FNP-223

Trial Overview 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.

Participant Groups

Group I: FNP-223 Experimental Treatment 1 Intervention

Participants will receive FNP-223 orally (PO), 3 times daily (TID).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo, PO, TID.

Who Is Running the Clinical Trial?

Ferrer Internacional S.A.

Lead Sponsor

Trials

27

Recruited

11,700+

Findings from Research

The use of F-THK5351 PET imaging in a 71-year-old man diagnosed with probable progressive supranuclear palsy (PSP) demonstrates the potential of new tau-PET ligands to visualize tau-protein distribution, which is linked to neurodegeneration in PSP.

This imaging technique may improve the diagnosis of PSP, which is often underdiagnosed due to its symptoms overlapping with other conditions, by providing clearer insights into the presence and progression of tau-protein aggregates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Added Value of Tau-PET in the Assessment of Progressive Supranuclear Palsy. López-Mora, DA., Fernández León, A., Lleó, A., et al.[2021]

The study involved 15 patients with progressive supranuclear palsy (PSP) who underwent [18F]FDDNP PET scanning, revealing that this imaging probe effectively visualizes tau fibrillar aggregates in the brain, particularly in subcortical areas, regardless of disease severity.

[18F]FDDNP PET imaging demonstrated distinct binding patterns in PSP patients compared to controls and those with Parkinson's disease, suggesting its potential as a diagnostic tool and a biomarker for monitoring tau pathology progression and treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET imaging of neuropathology in tauopathies: progressive supranuclear palsy. Kepe, V., Bordelon, Y., Boxer, A., et al.[2021]

In a study of 17 patients with progressive supranuclear palsy (PSP), increased uptake of the 18F-THK5351 PET tracer was observed in specific brain regions, such as the globus pallidus and red nucleus, indicating a potential biomarker for diagnosing PSP.

Higher levels of tracer uptake were associated with more severe symptoms, such as oculomotor dysfunction and postural instability, suggesting that 18F-THK5351 PET imaging can enhance diagnostic certainty and correlate with the severity of PSP symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-THK5351 PET imaging in patients with progressive supranuclear palsy: associations with core domains and diagnostic certainty. Hsu, JL., Chen, SH., Hsiao, IT., et al.[2021]

The age-adjusted prevalence of progressive supranuclear palsy (PSP) was found to be 2.95 cases per 100,000 people in 2016, which is lower than previously reported figures in other studies.

Common symptoms such as gait abnormalities, joint pain, and fatigue were frequently observed in patients up to five years before their official diagnosis, suggesting that earlier identification of PSP could be improved by recognizing these antecedent conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Features of Patients With Progressive Supranuclear Palsy in an US Insurance Claims Database. Viscidi, E., Litvan, I., Dam, T., et al.[2021]

In a study involving 187 patients with progressive supranuclear palsy (PSP), the PSP-Rating Scale was identified as the most efficient measure for detecting significant changes in disease progression, requiring only 51 patients per group for a 50% change over one year.

The study found no detectable placebo effect on the PSP-Rating Scale or the Schwab and England Activities of Daily Living, suggesting that these scales can reliably assess treatment efficacy in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Power calculations and placebo effect for future clinical trials in progressive supranuclear palsy. Stamelou, M., Schöpe, J., Wagenpfeil, S., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Added Value of Tau-PET in the Assessment of Progressive Supranuclear Palsy. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

PET imaging of neuropathology in tauopathies: progressive supranuclear palsy. [2021]

3. England pubmed.ncbi.nlm.nih.gov

18F-THK5351 PET imaging in patients with progressive supranuclear palsy: associations with core domains and diagnostic certainty. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Features of Patients With Progressive Supranuclear Palsy in an US Insurance Claims Database. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Power calculations and placebo effect for future clinical trials in progressive supranuclear palsy. [2021]