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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change From Baseline to Week 52 in the PSPRS Outcome — Baseline to Week 52
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) — Baseline to Week 52 Clinically significant changes in vital signs, clinical laboratory evaluations, physical examinations, and electrocardiogram (ECG) are included in TEAEs.
Number of Participants Experiencing Serious Adverse Events (SAEs) — Baseline to Week 52
Trial sites (44)
Facility
City
Region
Status
The Neurology Center of Southern California - Carlsbad
Carlsbad
California
UCSF Weill Institute for Neurosciences
San Francisco
California
Rocky Mountain Movement Disorders Center
Denver
Colorado
University of Miami Miller School of Medicine
Miami
Florida
Augusta University
Augusta
Georgia
Massachusetts General Hospital
Boston
Massachusetts
Quest Research Institute
Farmington Hills
Michigan
Robert & John M. Bendheim Parkinson and Movement Disorders Center at Mount Sinai
New York
New York
Columbia University Irving Medical Center
New York
New York
Duke Neurology
Durham
North Carolina
Vanderbilt University Medical Center
Nashville
Tennessee
Central Texas Neurology Consultants
Round Rock
Texas
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
+ 4 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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