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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Progressive Supranuclear Palsy

In brief

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.

Key facts

Study ID

NCT06355531

Run by

Ferrer Internacional S.A.

People needed

241

Starts

2024-07-23

Expected to finish

2026-11-01

Last updated by the study team

2025-10-15

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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