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New pill aims to slow rare brain disease in landmark trial

NCT ID NCT06355531

Disease control Sponsor: Ferrer Internacional S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests an oral drug called FNP-223 in 241 people with progressive supranuclear palsy (PSP), a rare brain disorder that causes problems with balance, eye movement, and thinking. The study compares the drug to a placebo over 52 weeks to see if it can slow the disease's progression and is safe. Participants must be 50-80 years old and have a specific type of PSP.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FNP-223 (oral tablet)
What this could lead to
If successful, this could point toward a treatment that slows the progression of progressive supranuclear palsy, a rare and devastating brain disease.
What could go wrong
This is an early Phase 2 trial with only 241 participants, so results may not confirm benefit. The drug may cause side effects or fail to slow the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

241 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Disease Progression progressive supranuclear palsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Progressive supranuclear palsy

Contacts and locations

Locations

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Azienda Ospedale Università di Padova

    Padova, 35128, Italy

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

    Salerno, 84081, Italy

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126, Italy

  • Campus Neurológico Senior - Torres Vedras

    Torres Vedras, 2560-280, Portugal

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006, Spain

  • Duke Neurology

    Durham, North Carolina, 27705, United States

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46086, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Cruces

    Barakaldo, 48903, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital Universitario de Navarra

    Pamplona, 31008, Spain

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Hôpital Pierre-Paul Riquet

    Toulouse, 31059, France

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, 75013, France

  • Hôpital de la Timone

    Marseille, 13005, France

  • IRCCS Istituto Delle Scienze Neurologiche di Bologna

    Bologna, 40139, Italy

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

    Roma, 00163, Italy

  • L'Hôpital Universitaire Carémeau

    Nîmes, 30029, France

  • Ludwig-Maximilians-Universität München (LMU)

    Munich, 81377, Germany

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mazowiecki Szpital Bródnowski w Warszawie

    Warsaw, 03-242, Poland

  • Neurologia Śląska Centrum Medyczne

    Katowice, 40-571, Poland

  • Neurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson

    Beelitz, 14547, Germany

  • Newcastle Upon Tyne Hospitals

    Newcastle, NE4 5PL, United Kingdom

  • Pécsi Tudományegyetem Általános Orvostudományi Kar

    Pécs, 7623, Hungary

  • 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

  • Rocky Mountain Movement Disorders Center

    Denver, Colorado, 80113, United States

  • The Neurology Center of Southern California - Carlsbad

    Carlsbad, California, 92011, United States

  • UCSF Weill Institute for Neurosciences

    San Francisco, California, 94158, United States

  • University College London Hospitals

    London, NW1 ePG, United Kingdom

  • University Hospital Southampton

    Southampton, SO16 6YD, United Kingdom

  • University of Cambridge

    Cambridge, CB2 3EB, United Kingdom

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Leipzig

    Leipzig, 04103, Germany

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

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