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Clinical Trials in Germany / NCT06355531
Active, not recruiting Phase 2

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

NCT06355531 · tracked via the Priya Life Science Germany tracker
Sponsor
Ferrer Internacional S.A
Phase
Phase 2
Started
2024-07-23
Last updated
2025-10-15

Condition(s) studied

Progressive Supranuclear Palsy

Investigational drug(s) / intervention(s)

FNP-223Placebo

FNP-223: Oral tablets

Placebo: Oral tablets

Study 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.

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)

Trial sites (44)

FacilityCityRegionStatus
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.

Other trials for the same condition

Official registry record

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.

View NCT06355531 on ClinicalTrials.gov ↗ ← All trials in Germany