- Study Director: Courtney Lane-Donovan, MD, PhD
- Sponsor: Ferrer Internacional SA
- Status: Recruiting
- Official Study 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)
- ClinicalTrials.gov Identifier: NCT06355531
- Conditions Studied: Progressive supranuclear palsy (PSP)
- Intervention: FNP-223
- Phase: Phase 2
- Duration of Participation: Up to 52 weeks (1 year) including the screening period
Purpose of the Study
The PROSPER trial is designed to assess the efficacy of FNP-223 in slowing disease progression in participants with progressive supranuclear palsy (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
- 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.
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.
What to Expect
Testing: Neurological and physical examinations, MRIs, at least two lumbar punctures, cognitive testing and neuropsychiatric assessments, telephone calls, blood and urine specimen collection, and vital signs
The Frequency of Visits: Every 4 weeks
Materials Needed Before Evaluation: Prior to participating in the trial, the patient will need a diagnosis of probable progressive supranuclear palsy (PSP).
Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits.
Contact Information
Coordinator: [email protected]
Clinical Trials Nurse: Whitney Walker, MS, CNS, RN – [email protected], 415.353.7532
