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

Launched by FERRER INTERNACIONAL S.A. · Apr 3, 2024

Keywords

ClinConnect Summary

The PROSPER trial is a research study that aims to evaluate a new treatment called FNP-223 for people with Progressive Supranuclear Palsy (PSP), a condition that affects movement and balance. The study will last for 52 weeks and will look at whether FNP-223 can help slow down the progression of PSP, using a specific rating scale to track changes in symptoms. It will also assess how safe and tolerable this treatment is for participants during this time.

To participate in this trial, individuals must be between 50 and 80 years old and have a diagnosis of possible or probable PSP-Richardson Syndrome, which includes specific symptoms like difficulty moving their eyes and postural instability. They should also be able to walk independently with minimal help. Participants will need a caregiver who can accompany them to study visits and help provide information. Throughout the trial, participants can expect regular check-ups to monitor their health and response to the treatment, and they will be contributing to research that may improve care for others with PSP in the future.

Gender

ALL

Eligibility criteria

• 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.