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Virus Therapy

FNP-223 for Progressive Supranuclear Palsy

Phase 2
Recruiting
Research Sponsored by Ferrer Internacional S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of PSP symptoms ≤3 years
Body weight range ≥43 kg/95 lbs to ≤120 kg/265 lbs
Must not have
Non-PSP- RS Movement Disorders or other central nervous system (CNS) Diseases
Participants with known genetic mutation (based on familiar or clinical history)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 4 and week 16
Awards & highlights

Summary

"This trial aims to see if FNP-223 can slow down the progression of PSP in participants over 52 weeks. It will also look at the safety and tolerability of FNP-223 in

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be closely monitored for any adverse reactions to FNP-223 throughout the study period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight is between 95 and 265 lbs.
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I can walk on my own or with a cane.
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I am between 50 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have PSP-RS movement disorders or other CNS diseases.
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I have a known genetic mutation based on my family or medical history.
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My recent brain MRI shows a condition that is not PSP.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 4 and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 4 and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline to Week 52 in the PSPRS Outcome
Number of Participants Experiencing Serious Adverse Events (SAEs)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Change From Baseline to Week 52 Participant Global Impression of Severity Scale (PGI-S)
Change From Baseline to Week 52 in Caregiver Global Impression of Severity Scale (CaGI-S)
Change From Baseline to Week 52 in Clinical Global Impression of Severity Scale (CGI-S)
+7 more

Trial Design

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.

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Who is running the clinical trial?

Ferrer Internacional S.A.Lead Sponsor
25 Previous Clinical Trials
11,448 Total Patients Enrolled
~147 spots leftby Nov 2026