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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
241
Change From Baseline to Week 52 in the PSPRS Outcome
Time frame: Baseline to Week 52
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Clinically significant changes in vital signs, clinical laboratory evaluations, physical examinations, and electrocardiogram (ECG) are included in TEAEs.
Time frame: Baseline to Week 52
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Baseline to Week 52
Change From Baseline to Week 52 in Clinical Global Impression of Severity Scale (CGI-S)
Time frame: Baseline to Week 52
Change From Baseline to Week 52 Participant Global Impression of Severity Scale (PGI-S)
Time frame: Baseline to Week 52
Change From Baseline to Week 52 in Caregiver Global Impression of Severity Scale (CaGI-S)
Time frame: Baseline to Week 52
Slope of Decline in PSPRS
Time frame: Baseline to Week 52
Change From Baseline to Week 52 in Individual Subitems of PSPRS
Time frame: Baseline to Week 52
Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale
Time frame: Baseline to Week 52
Change From Baseline to Week 52 in PSP Clinical Deficits Scale (PSP-CDS)
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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
...and 34 more locations
Time frame: Baseline to Week 52
Change From Baseline to Week 52 in Montreal Cognitive Assessment (MoCA)
Time frame: Baseline to Week 52
Change From Baseline to Week 52 in PSP Quality of Life Scale (PSP-QoL)
Time frame: Baseline to Week 52
Pharmacokinetic characterization of FNP-223
Mean plasma concentration of FNP-223.
Time frame: At Week 4 and Week 16