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

Description

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.

Conditions

Progressive Supranuclear Palsy

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Progressive Supranuclear Palsy
Intervention / Treatment

-

Contacts and Locations

Carlsbad

The Neurology Center of Southern California - Carlsbad, Carlsbad, California, United States, 92011

San Francisco

UCSF Weill Institute for Neurosciences, San Francisco, California, United States, 94158

Denver

Rocky Mountain Movement Disorders Center, Denver, Colorado, United States, 80113

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Farmington Hills

Quest Research Institute, Farmington Hills, Michigan, United States, 48334

New York

Robert & John M. Bendheim Parkinson and Movement Disorders Center at Mount Sinai, New York, New York, United States, 10029

Durham

Duke Neurology, Durham, North Carolina, United States, 27705

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37212

Round Rock

Central Texas Neurology Consultants, Round Rock, Texas, United States, 78681

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 ≤3 years.
  • * 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.
  • * 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.
  • * Score of 3 on any functional domain in the PSP-CDS.
  • * Participants with known 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.
  • * For the optional substudy only: Contraindication or refusal to undergo 2 lumbar punctures for obtaining CSF.
  • * Contraindication or inability to tolerate MRI for volumetric brain MRI assessments throughout the study.

Ages Eligible for Study

50 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ferrer Internacional S.A.,

Study Record Dates

2026-11