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Progressive Supranuclear PalsyPhase 2NCT06355531

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

A Phase 2 study testing FNP-223 in people with Progressive Supranuclear Palsy, run by Ferrer Internacional S.A. at 44 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Progressive Supranuclear Palsy
What is being tested?
FNP-223
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
241 participants
Where
44 sitesin 9 countries
Study dates
23 Jul 2024to Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

44 sites in 9 countries.

44 sites in 9 countries

United States12 sites

  • Augusta University

    Augusta, Georgia, 30912

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • The Neurology Center of Southern California - Carlsbad

    Carlsbad, California, 92011

  • Rocky Mountain Movement Disorders Center

    Denver, Colorado, 80113

  • Duke Neurology

    Durham, North Carolina, 27705

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

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

    New York, New York, 10029

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • UCSF Weill Institute for Neurosciences

    San Francisco, California, 94158

Other trials in United States

Spain9 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitario Cruces

    Barakaldo, 48903

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de Navarra

    Pamplona, 31008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46086

Other trials in Spain

France5 sites

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076

  • Hôpital de la Timone

    Marseille, 13005

  • L'Hôpital Universitaire Carémeau

    Nîmes, 30029

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, 75013

  • Hôpital Pierre-Paul Riquet

    Toulouse, 31059

Other trials in France

Italy5 sites

  • IRCCS Istituto Delle Scienze Neurologiche di Bologna

    Bologna, 40139

  • Azienda Ospedale Università di Padova

    Padova, 35128

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

    Roma, 00163

  • Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona

    Salerno, 84081

Other trials in Italy

Germany4 sites

  • Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson

    Beelitz, 14547

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Ludwig-Maximilians-Universität München (LMU)

    Munich, 81377

Other trials in Germany

United Kingdom4 sites

  • University of Cambridge

    Cambridge, CB2 3EB

  • University College London Hospitals

    London, NW1 ePG

  • Newcastle Upon Tyne Hospitals

    Newcastle, NE4 5PL

  • University Hospital Southampton

    Southampton, SO16 6YD

Other trials in United Kingdom

Poland2 sites

  • Neurologia Śląska Centrum Medyczne

    Katowice, 40-571

  • Mazowiecki Szpital Bródnowski w Warszawie

    Warsaw, 03-242

Other trials in Poland

Portugal2 sites

  • Hospital de Braga

    Braga, 4710-243

  • Campus Neurológico Senior - Torres Vedras

    Torres Vedras, 2560-280

Other trials in Portugal

Hungary1 site

  • Pécsi Tudományegyetem Általános Orvostudományi Kar

    Pécs, 7623

Other trials in Hungary

About this study

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)

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.

Being tested
FNP-223, Placebo
Keywords
Progressive Supranuclear Palsy, Disease progression, FNP-223
Medical subject headings
Supranuclear Palsy, Progressive, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FNP-223Drug

    Oral tablets

  • PlaceboDrug

    Oral tablets

Study groups in NCT06355531
Study groupRoleWhat they receive
FNP-223ExperimentalParticipants will receive FNP-223 orally (PO), 3 times daily (TID).
Receives: Drug: FNP-223
PlaceboPlacebo comparatorParticipants will receive matching placebo, PO, TID.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 52 in the PSPRS Outcome

    Measured: Baseline to Week 52

  2. 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.

    Measured: Baseline to Week 52

  3. Number of Participants Experiencing Serious Adverse Events (SAEs)

    Measured: Baseline to Week 52

Secondary outcomes (10)

  1. Change From Baseline to Week 52 in Clinical Global Impression of Severity Scale (CGI-S)

    Measured: Baseline to Week 52

  2. Change From Baseline to Week 52 Participant Global Impression of Severity Scale (PGI-S)

    Measured: Baseline to Week 52

  3. Change From Baseline to Week 52 in Caregiver Global Impression of Severity Scale (CaGI-S)

    Measured: Baseline to Week 52

  4. Slope of Decline in PSPRS

    Measured: Baseline to Week 52

  5. Change From Baseline to Week 52 in Individual Subitems of PSPRS

    Measured: Baseline to Week 52

  6. Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale

    Measured: Baseline to Week 52

  7. Change From Baseline to Week 52 in PSP Clinical Deficits Scale (PSP-CDS)

    Measured: Baseline to Week 52

  8. Change From Baseline to Week 52 in Montreal Cognitive Assessment (MoCA)

    Measured: Baseline to Week 52

  9. Change From Baseline to Week 52 in PSP Quality of Life Scale (PSP-QoL)

    Measured: Baseline to Week 52

  10. Pharmacokinetic characterization of FNP-223

    Mean plasma concentration of FNP-223.

    Measured: At Week 4 and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start23 Jul 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06355531
Sponsor's protocol ID
FNP223-CT-2301
Status last verified
Sep 2025
First submitted
26 Mar 2024
Last updated
15 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pokorny R, Ryan JM, Abd-Elaziz K, van den Berg F, Rabiner E, Searle GE, Schneider M, Wiessner C, Stallaert JF, Permanne B, Quattropani A, Beher D. Safety, Tolerability, Pharmacokinetics, and Brain Target Occupancy of the OGA Inhibitor ASN90 in Healthy Participants. Mov Disord. 2026 Feb;41(2):436-444. doi: 10.1002/mds.70104. Epub 2025 Nov 15.

    PubMed 41239890

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FNP-223 in people with Progressive Supranuclear Palsy, run by Ferrer Internacional S.A. at 44 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Spain, France, Italy, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 52 in the PSPRS Outcome (time frame: Baseline to Week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06355531, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.

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