A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP)
This research, called the PROSPER trial, is trying to find out if a new drug, FNP-223, can help slow down the progression of Progressive Supranuclear Palsy (PSP). PSP is a rare brain condition that causes serious problems with walking, balance, movement, speech, and swallowing. Participants in this study will either receive FNP-223 or a 'placebo', which looks like the real drug but contains no active medicine. This helps researchers understand the true effects of FNP-223. The study will last for 52 weeks (about a year) and will involve people between 50 and 80 years old who have been diagnosed with PSP. The main goals are to check how well FNP-223 works in slowing the disease and to make sure it is safe and well-tolerated. It's a key step in finding new ways to manage PSP.
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¿De qué trata este estudio?
This clinical trial is designed to investigate a new medication called FNP-223 for people living with Progressive Supranuclear Palsy (PSP). PSP is a rare and complex condition that affects the brain, leading to challenges with movement, balance, speech, and eye movements. Currently, there's no cure for PSP, and treatments mainly focus on managing symptoms. This study aims to explore whether FNP-223 could be a step forward by potentially slowing down how quickly the disease progresses.
Researchers will be looking very closely at how participants respond over 52 weeks, which is about a year. They will use a special scoring system called the PSP Rating Scale (PSPRS) to measure any changes in the disease's effects. Alongside checking if the medication helps, a major focus is also on safety. It's really important to find out if FNP-223 causes any unwanted side effects and if people can tolerate taking it.
By comparing FNP-223 to a placebo (a dummy medicine), the scientists can get a clearer picture of the drug's actual impact. This type of research is vital because it helps doctors understand new treatments better. The findings from studies like this are crucial for developing new and effective ways to help people with PSP in the future, offering hope for better management of the condition.
Puntos clave
- This study is testing a new drug, FNP-223, for people with PSP.
- The main goals are to see if FNP-223 can slow PSP progression and if it's safe.
- Participants will receive either FNP-223 or a placebo (dummy medicine).
- The study lasts for about one year and involves regular clinic visits.
- Eligibility includes specific age, PSP diagnosis criteria, and having a caregiver.
- La participación es voluntaria, y puedes retirarte en cualquier momento.
¿Quién puede ser elegible?
To be considered for this study, you would generally need to be a man or woman aged between 50 and 80 years old. You must have received a diagnosis of PSP, specifically the Richardson's Syndrome type, within the last three years. The diagnosis needs to meet particular criteria related to eye movement problems or issues with balance and falls that started early in your condition.
There are also a few other things they'll check. You should be able to walk by yourself or with just a little help, like using a cane. Your weight needs to be within a certain range, and you shouldn't be living in a nursing home or dementia care facility (assisted living is usually okay). It's also important to have a caregiver or study partner who can come with you to appointments and help share information about your health.
You wouldn't be able to join if you have other neurological conditions that might be confused with PSP, or if specific brain scans show something different. Also, if your PSP is known to be caused by certain genetic changes, or if you have very severe symptoms that affect your daily activities, you might not be eligible.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Are you between 50 and 80 years old?
- Were you diagnosed with PSP (Richardson's Syndrome type) within the last 3 years?
- Can you walk independently or with only minimal help (e.g., a cane)?
- Do you have a caregiver or study partner who can attend appointments with you?
- Are you able to attend regular clinic visits for about a year?
- Do you currently live in an assisted living facility or your own home (not a nursing/dementia care facility)?
¿En qué consiste la participación?
If you decide to take part, you'll be in the study for about 52 weeks, which is a year. Throughout this time, you'll have regular visits to the study clinic. At these visits, doctors and nurses will carry out various checks and assessments, including physical exams, blood tests, and special tests to measure your PSP symptoms using scales like the PSPRS. You won't know if you're receiving the active study drug (FNP-223) or a placebo (a dummy pill), as this is a 'blinded' study to ensure fair results. Your caregiver or study partner will also be a key part of your participation, attending visits with you and helping to provide information. There will likely be an initial screening period to confirm you meet all the study requirements, followed by the treatment period and then a final visit or follow-up.
Riesgos y beneficios potenciales
Locations (44)
- The Neurology Center of Southern California - CarlsbadCódigo postal verificadoCarlsbad, United States
- UCSF Weill Institute for NeurosciencesCódigo postal verificadoSan Francisco, Estados Unidos
- Rocky Mountain Movement Disorders CenterCódigo postal verificadoDenver, Estados Unidos
- University of Miami Miller School of MedicineCódigo postal verificadoMiami, United States
- Augusta UniversityCódigo postal verificadoAugusta, United States
- Hospital General de MassachusettsCódigo postal verificadoBoston, Estados Unidos
- Quest Research InstituteCódigo postal verificadoFarmington Hills, United States
- Robert & John M. Bendheim Parkinson and Movement Disorders Center at Mount SinaiCódigo postal verificadoNueva York, Estados Unidos
- Columbia University Irving Medical CenterCódigo postal verificadoNueva York, Estados Unidos
- Duke NeurologyCódigo postal verificadoDurham, Estados Unidos
- Vanderbilt University Medical CenterCódigo postal verificadoNashville, Estados Unidos
- Central Texas Neurology ConsultantsCódigo postal verificadoRound Rock, United States
Preguntas comunes
What is Progressive Supranuclear Palsy (PSP)?
PSP is a rare brain condition that causes problems with balance, movement, swallowing, speech, and eye movements. It's a progressive condition, meaning it tends to get worse over time.
What is FNP-223?
FNP-223 is a new medication being tested in this study to see if it can help slow down the progression of PSP. It's not yet approved for general use.
¿Qué es un 'placebo'?
A placebo is a substance that looks exactly like the study drug but doesn't have any active medicine in it. It's used in trials to help researchers understand if the study drug's effects are real or due to other factors.
¿Cuánto tiempo durará el estudio?
If you join, your active participation in the study will last for about 52 weeks, which is one year.
Do I need a caregiver to participate?
Yes, you will need a caregiver or study partner who can attend appointments with you and has regular contact with you (at least 7 hours per week) to help provide information about your health.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.