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

NCT06355531 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FNP223-CT-2301
• Study Type: interventional
• Target: 241
• Locations: 9 countries
• Sites: 44

Brief Summary

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.

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive Supranuclear Palsy; Disease progression; FNP-223

Outcome Measures

Primary Outcomes (3)

• Change From Baseline to Week 52 in the PSPRS Outcome

  Baseline to Week 52

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

  Clinically significant changes in vital signs, clinical laboratory evaluations, physical examinations, and electrocardiogram (ECG) are included in TEAEs.

  Baseline to Week 52

• Number of Participants Experiencing Serious Adverse Events (SAEs)

  Baseline to Week 52

Secondary Outcomes (10)

• 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

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

  Baseline to Week 52

• Slope of Decline in PSPRS

  Baseline to Week 52

• Change From Baseline to Week 52 in Individual Subitems of PSPRS

  Baseline to Week 52

Study Arms (2)

FNP-223

EXPERIMENTAL

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

Drug: FNP-223

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo, PO, TID.

Drug: Placebo

Interventions

FNP-223 DRUG

Oral tablets

FNP-223

Placebo DRUG

Oral tablets

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferrer Internacional S.A.: lead

Study Sites (44)

The Neurology Center of Southern California - Carlsbad

Carlsbad, California, 92011, United States

Location

UCSF Weill Institute for Neurosciences

San Francisco, California, 94158, United States

Location

Rocky Mountain Movement Disorders Center

Denver, Colorado, 80113, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Robert & John M. Bendheim Parkinson and Movement Disorders Center at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Duke Neurology

Durham, North Carolina, 27705, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Hôpital de la Timone

Marseille, 13005, France

Location

L'Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Hôpital Universitaire Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital Pierre-Paul Riquet

Toulouse, 31059, France

Location

Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson

Beelitz, 14547, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Ludwig-Maximilians-Universität München (LMU)

Munich, 81377, Germany

Location

Pécsi Tudományegyetem Általános Orvostudományi Kar

Pécs, 7623, Hungary

Location

IRCCS Istituto Delle Scienze Neurologiche di Bologna

Bologna, 40139, Italy

Location

Azienda Ospedale Università di Padova

Padua, 35128, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126, Italy

Location

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

Roma, 00163, Italy

Location

Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona

Salerno, 84081, Italy

Location

Neurologia Śląska Centrum Medyczne

Katowice, 40-571, Poland

Location

Mazowiecki Szpital Bródnowski w Warszawie

Warsaw, 03-242, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Campus Neurológico Senior - Torres Vedras

Torres Vedras, 2560-280, Portugal

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Universitario Cruces

Barakaldo, 48903, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46086, Spain

Location

University of Cambridge

Cambridge, CB2 3EB, United Kingdom

Location

University College London Hospitals

London, NW1 ePG, United Kingdom

Location

Newcastle Upon Tyne Hospitals

Newcastle, NE4 5PL, United Kingdom

Location

University Hospital Southampton

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Pokorny R, Ryan JM, Abd-Elaziz K, van den Berg F, Rabiner E, Searle GE, Schneider M, Wiessner C, Stallaert JF, Permanne B, Quattropani A, Beher D. Safety, Tolerability, Pharmacokinetics, and Brain Target Occupancy of the OGA Inhibitor ASN90 in Healthy Participants. Mov Disord. 2025 Nov 15. doi: 10.1002/mds.70104. Online ahead of print.

  PMID: 41239890 DERIVED

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Disease Progression

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 9, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); US (12); HU (1); PL (2); DE (4); PT (2); ES (9); FR (5); IT (5)