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Study of FNP-223 tablets to slow disease progression in patients with Progressive Supranuclear Palsy (PSP)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Progressive Supranuclear Palsy (PSP), a rare brain disorder that affects movement, balance, and eye control. The research evaluates a new medication called FNP-223, which is given as a film-coated tablet taken by mouth. The purpose is to determine if this medication can slow down the progression of PSP symptoms over a period of 52 weeks.

The study will compare FNP-223 with a placebo to see how effective and safe the medication is for people with PSP. Participants will be randomly assigned to receive either the study medication or placebo, and neither the participants nor the doctors will know which treatment is being given during the study period.

Throughout the 52-week study period, participants will be monitored for changes in their condition using various assessments that measure movement ability, daily activities, thinking skills, and overall quality of life. The study will also track any side effects that may occur during treatment. Regular check-ups will help ensure participant safety and evaluate how well the medication is working.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    The study begins with an assessment to confirm the diagnosis of progressive supranuclear palsy (PSP)

    Initial tests include evaluation of walking ability (minimum 10 steps with possible use of a cane)

    A cognitive assessment using the Montreal Cognitive Assessment (MoCA) will be performed, requiring a score of 23 or higher

  2. Step 2

    Treatment period start

    The treatment involves taking FNP-223 or placebo in the form of film-coated tablets

    The medication will be taken orally

    A caregiver who spends at least 7 hours per week with the patient must be present during study visits

  3. Step 3

    52-week monitoring period

    Regular assessments will track changes in disease progression using the PSP Rating Scale

    Monitoring includes physical examinations, laboratory tests, and ECG measurements

    Assessment of daily living activities and quality of life will be conducted

    Safety monitoring includes vital signs and laboratory evaluations

  4. Step 4

    Final evaluation

    Final assessment of disease progression after 52 weeks of treatment

    Completion of all rating scales and quality of life measurements

    Final safety assessment including physical examination and laboratory tests

Who can join the trial?

11 criteria

  • Age between 50 and 80 years old at the time of consent
  • Must be able to understand and agree to participate in the study and follow study procedures
  • Must have a caregiver or study partner who: - Spends at least 7 hours per week with the patient - Can attend study visits - Can provide information about medications and condition - Must also provide consent
  • Must have PSP symptoms for 3 years or less before screening
  • Must have at least one of these symptoms: - Problems with up and down eye movements - Slow vertical eye movements AND balance problems with falls within first 3 years of symptoms
  • Must score 40 or less on the PSP Rating Scale (a tool that measures disease severity)
  • Must be able to walk independently or with minimal help (like using a cane) for at least 10 steps
  • Must score 23 or higher on the MoCA test (a test that checks thinking and memory abilities)
  • Body weight must be between 43 kg (95 lbs) and 120 kg (265 lbs)
  • Must live outside of nursing homes or dementia care facilities (assisted living is acceptable)
  • For women who can become pregnant and men with partners who can become pregnant: must agree to use effective birth control during the study and for 30 days after the last dose

Who cannot join the trial?

15 criteria

  • Age below 40 or above 80 years
  • Diagnosis of any neurological disorder other than Progressive Supranuclear Palsy (PSP)
  • Participation in other clinical trials within the last 30 days
  • History of significant heart disease or recent heart attack (within 6 months)
  • Severe liver or kidney dysfunction
  • Uncontrolled high blood pressure (hypertension)
  • Current active cancer or cancer treatment
  • History of stroke or brain hemorrhage
  • Pregnancy or breastfeeding
  • Unable to provide informed consent
  • Unable to attend regular study visits
  • Taking medications that could interfere with the study drug
  • Severe psychiatric conditions that could affect study participation
  • History of alcohol or drug abuse within the past year
  • Major surgery planned during the study period
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Investigated drugs

FNP-223 is an experimental oral medication being studied for its potential to slow down the progression of Progressive Supranuclear Palsy (PSP), a rare brain disorder. This medication is being tested to see if it can help patients with PSP maintain their physical abilities and daily functions for a longer time. The medication is taken by mouth and is being evaluated for both its effectiveness and safety in treating PSP symptoms.

What is already known about the treatment

FNP-223 - An investigational oral medication currently being studied in Phase 2 clinical trials for the treatment of Progressive Supranuclear Palsy (PSP), a rare neurological disorder. This drug is administered orally and is being evaluated for its potential to slow disease progression in PSP patients. While the exact molecular mechanism of action is still under investigation as part of ongoing clinical research, the medication is being tested through a randomized, double-blind, placebo-controlled study to assess both its efficacy and safety over a 52-week treatment period. The primary measurement of its effectiveness is being conducted using the PSP Rating Scale (PSPRS), which evaluates disease progression in patients.

Investigated diseases

Progressive Supranuclear Palsy (PSP) - A rare brain disorder that causes serious problems with walking, balance, eye movements, and swallowing. The condition gradually damages specific areas of the brain above nerve cell clusters called nuclei that control eye movements. People with PSP develop difficulties with balance and walking, which worsen over time. The disease also causes problems with eye movement, particularly with looking up and down, along with speech difficulties and trouble swallowing. Additionally, people may experience changes in mood and behavior, as well as mild thinking problems. The condition typically develops in people over the age of 60, though it can occur earlier.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510366-28-00Protocol codeFNP223-CT-2301Estimated enrolment241 patientsSponsorFerrer Internacional S.A.

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