ACTIVE_NOT_RECRUITING

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

Conditions

Progressive Supranuclear Palsy Disease progression FNP-223

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2024-07-23

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06355531

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.

Ages Eligible for Study:50 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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. * 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.

Inclusion Criteria

Exclusion 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.

* 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.
* 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.

Contacts and Locations

Study Locations (Sites)

The Neurology Center of Southern California - Carlsbad

Carlsbad, California, 92011

United States

UCSF Weill Institute for Neurosciences

San Francisco, California, 94158

United States

Rocky Mountain Movement Disorders Center

Denver, Colorado, 80113

United States

University of Miami Miller School of Medicine

Miami, Florida, 33136

United States

Augusta University

Augusta, Georgia, 30912

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Quest Research Institute

Farmington Hills, Michigan, 48334

United States

Robert & John M. Bendheim Parkinson and Movement Disorders Center at Mount Sinai

New York, New York, 10029

United States

Columbia University Irving Medical Center

New York, New York, 10032

United States

Duke Neurology

Durham, North Carolina, 27705

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37212

United States

Central Texas Neurology Consultants

Round Rock, Texas, 78681

United States

Collaborators and Investigators

Sponsor: Ferrer Internacional S.A.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-23

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-07-23

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

Progressive Supranuclear Palsy
Disease progression
FNP-223

Additional Relevant MeSH Terms

Progressive Supranuclear Palsy