Skip to main content
Delfa

← Trials/Trial dossier/NCT06355531

Active not recruitingPhase 2

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP)

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)

Asset

FNP-223

Listed sites

44

Recruiting sites

-

Enrollment

241

actual

Study population

Frontotemporal dementia

Key I/E criteria

•MoCA ≥23•Study partner/caregiver required

Primary endpoints

•The PSPRS Outcome•Treatment-emergent Adverse Events (TEAEs)•Serious Adverse Events (SAEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDFNP223-CT-2301
NCT IDNCT06355531

Timeline

Milestones

Study first posted2024-04-09actual
Study start2024-07-23actual
Last update posted2025-10-15actual
Primary completion2026-11estimated (month precision)
Study completion2026-11estimated (month precision)

Assets

Drug assets

FNP-223

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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:

1. Vertical supranuclear gaze palsy.

2. 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 ≤40.
•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

Exclusion criteria

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.

Procedures

•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.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
5
Safety / tolerability / PK
3
Caregiver / quality of life
2
Global cognition
1
Function / daily living
1
Other clinical outcomes
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Change From Baseline to Week 52 in Montreal Cognitive Assessment (MoCA)

Time frame:Baseline to Week 52

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale

Time frame:Baseline to Week 52

change from baseline, improvement

Caregiver / quality of life

2 endpoints
Secondary/protocol endpoint

Change From Baseline to Week 52 in Caregiver Global Impression of Severity Scale (CaGI-S)

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 52 in PSP Quality of Life Scale (PSP-QoL)

Time frame:Baseline to Week 52

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Time frame:Baseline to Week 52

event count, event

Primary/protocol endpoint

Number of Participants Experiencing Serious Adverse Events (SAEs)

Time frame:Baseline to Week 52

event count, event

Secondary/protocol endpoint

Pharmacokinetic characterization of FNP-223

Time frame:At Week 4 and Week 16

concentration, descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Change From Baseline to Week 52 in Clinical Global Impression of Severity Scale (CGI-S)

Time frame:Baseline to Week 52

change from baseline, improvement

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Change From Baseline to Week 52 in the PSPRS Outcome

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 52 Participant Global Impression of Severity Scale (PGI-S)

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Slope of Decline in PSPRS

Time frame:Baseline to Week 52

descriptive

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 52 in Individual Subitems of PSPRS

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 52 in PSP Clinical Deficits Scale (PSP-CDS)

Time frame:Baseline to Week 52

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.