A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP)
NCT ID: NCT06355531
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
241 participants
INTERVENTIONAL
2024-07-23
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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FNP-223
Participants will receive FNP-223 orally (PO), 3 times daily (TID).
FNP-223
Oral tablets
Placebo
Participants will receive matching placebo, PO, TID.
Placebo
Oral tablets
Interventions
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FNP-223
Oral tablets
Placebo
Oral tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
80 Years
ALL
No
Sponsors
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Ferrer Internacional S.A.
INDUSTRY
Responsible Party
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Locations
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The Neurology Center of Southern California - Carlsbad
Carlsbad, California, United States
UCSF Weill Institute for Neurosciences
San Francisco, California, United States
Rocky Mountain Movement Disorders Center
Denver, Colorado, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Augusta University
Augusta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Robert & John M. Bendheim Parkinson and Movement Disorders Center at Mount Sinai
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Duke Neurology
Durham, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
Groupe Hospitalier Pellegrin
Bordeaux, , France
Hôpital de la Timone
Marseille, , France
L'Hôpital Universitaire Carémeau
Nîmes, , France
Hôpital Universitaire Pitié Salpêtrière
Paris, , France
Hôpital Pierre-Paul Riquet
Toulouse, , France
Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson
Beelitz, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Ludwig-Maximilians-Universität München (LMU)
Munich, , Germany
Pécsi Tudományegyetem Általános Orvostudományi Kar
Pécs, , Hungary
IRCCS Istituto Delle Scienze Neurologiche di Bologna
Bologna, , Italy
Azienda Ospedale Università di Padova
Padua, , Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
Roma, , Italy
Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona
Salerno, , Italy
Neurologia Śląska Centrum Medyczne
Katowice, , Poland
Mazowiecki Szpital Bródnowski w Warszawie
Warsaw, , Poland
Hospital de Braga
Braga, , Portugal
Campus Neurológico Senior - Torres Vedras
Torres Vedras, , Portugal
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Universitario Cruces
Barakaldo, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario de Navarra
Pamplona, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
University of Cambridge
Cambridge, , United Kingdom
University College London Hospitals
London, , United Kingdom
Newcastle Upon Tyne Hospitals
Newcastle, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Countries
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Other Identifiers
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FNP223-CT-2301
Identifier Type: -
Identifier Source: org_study_id
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