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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Universitaet Leipzig Leipzig Germany
Oncopole Claudius Regaud Toulouse France
Neurologia Slaska Centrum Medyczne Katowice Poland

Other Sites

Site Name City Country Status
Kliniken Beelitz GmbH Beelitz Germany
Mazowiecki Szpital Brodnowski Sp. z o.o. Warsaw Poland
Centre Hospitalier Universitaire De Nimes Nimes France
Hospital Universitario 12 De Octubre Madrid Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
CNS Saude Lda. Torres Vedras Portugal
Azienda Ospedaliera di Padova Padua Italy
Virgen del Rocío University Hospital Sevilla Spain
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Cruces Barakaldo Spain
Irccs San Raffaele Roma S.r.l. Rome Italy
Universita’ Di Pisa Pisa Italy
University Of Pecs Pecs Hungary
Hopital Beaujon Clichy France
Aunafddjga Pshyqfdi Hwlsbvul Dd Muzrjdrhr Marseille France
Uyfohdfqmxpejluhwghyu Dmvmaxtppey Apg Duesseldorf Germany
Kwordcyn dah Umhpabyxgyfi Mymbfjpi Akp Munich Germany
Hqcdnuil Ugmfgifsjguuy Hnykboyc Txchp y Puhyce Iuulhxyc Cwbffn dvcqxabvwzvcllifk (zfcc Badalona Spain
Hlltjlpc Uclveeqmtpfhh dn A Cpvaaj A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
06.09.2024
Germany Germany
Not recruiting
06.09.2024
Hungary Hungary
Not recruiting
06.09.2024
Italy Italy
Not recruiting
06.09.2024
Poland Poland
Not recruiting
06.09.2024
Portugal Portugal
Not recruiting
06.09.2024
Spain Spain
Not recruiting
06.09.2024

Trial locations

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.

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 ID:
2023-510366-28-00
Protocol code:
FNP223-CT-2301
NCT ID:
NCT06355531
Trial Phase:
Therapeutic exploratory (Phase II)

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