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NCT06355531

PHASE2

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

Sponsor: Ferrer Internacional S.A.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

241

Start Date

2024-07-23

Completion Date

2026-11

Last Updated

2025-10-15

Healthy Volunteers

Conditions

Progressive Supranuclear Palsy

Interventions

DRUG

FNP-223

Oral tablets

DRUG

Placebo

Oral tablets

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.

Locations (44)

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

Padova, 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