A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy
Researchers are conducting a Phase 3 clinical trial to test a new medicine called NIO752 for people living with a specific type of Progressive Supranuclear Palsy (PSP), called PSP Richardson Syndrome. This study aims to find out if NIO752 is effective in managing PSP symptoms and if it is safe for patients. Participants will be randomly assigned to receive either NIO752 or a placebo (a dummy treatment without any active medicine). This part of the study is 'double-blind', meaning neither the patient nor the doctor will know who is getting which treatment. After this initial period, all participants will be offered the chance to receive NIO752 in an extended, 'open-label' part of the study, where everyone knows what they're taking. The study involves people aged 41 to 81 with mild to moderate PSP.
Överblick
Vad handlar denna studie om?
Progressive Supranuclear Palsy (PSP) is a rare but serious condition that affects how your brain works, leading to problems with balance, movement, vision, and speech. There isn't a cure for PSP yet, and current treatments mainly focus on managing the symptoms.
This study, called a 'Phase 3' trial, is a very important step in testing a new medicine called NIO752. Researchers want to see if NIO752 can help improve the symptoms of PSP Richardson Syndrome and if it's safe to use. Finding new and better treatments is crucial for people living with PSP to improve their quality of life.
By taking part in studies like this, patients contribute to medical knowledge and help develop new medicines that could benefit many others in the future. It’s a chance to explore potential new ways to manage PSP.
Viktiga punkter
- This study is testing a new medicine, NIO752, for PSP Richardson Syndrome.
- It aims to see if the medicine is effective and safe.
- Participants will be randomly assigned to receive either the new medicine or a dummy treatment (placebo).
- A trusted 'study partner' is needed to help with your participation.
- The study involves regular clinic visits and careful monitoring of your health.
- Du kan när som helst avbryta ditt deltagande i studien utan att det påverkar din vård.
Vem kan vara berättigad?
To join this study, you would need to be between 41 and 81 years old. You must have been diagnosed with a specific type of PSP called PSP Richardson syndrome, and your symptoms should have started less than five years ago and be mild to moderate. You also need to have a trusted person, like a family member or close friend, who can help you with the study, provide information about your health, and spend at least five hours a week with you.
There are also some requirements about your physical abilities, such as being able to walk at least ten steps, possibly with a little help. Your thinking and memory will be checked to make sure they meet the study's requirements. Before you can join, you'll need to formally agree to take part by signing a consent form.
Some things might mean you can't join the study. These include having other serious brain conditions like Parkinson's disease, Alzheimer's, or certain types of stroke or head injury. You also couldn't join if you have other muscle or nerve conditions, or if brain scans show certain significant abnormalities. The study team will check all these details carefully with you.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Are you between 41 and 81 years old?
- Do you have a diagnosis of PSP Richardson syndrome, with symptoms starting in the last 5 years?
- Can you walk at least 10 steps, even with a little help?
- Do you have a reliable family member or friend who can be your study partner and spend at least 5 hours a week with you?
- Do you *not* have other serious neurological conditions like Parkinson's, Alzheimer's, or certain types of strokes?
Vad innebär deltagande?
If you decide to take part in this study, you'll be assigned by chance (like drawing lots) to one of two groups. Two out of every three participants will receive the new study medicine, NIO752, while one in three will receive a 'placebo', which looks exactly like NIO752 but contains no active medicine. Neither you nor your study doctor will know which one you're getting at first. This helps ensure the results are fair and accurate.
During this first part of the study, you'll have regular visits to the clinic for check-ups, assessments, and to receive your medication. The study team will monitor your health, symptoms, and any side effects very closely. After this main part of the study is complete, you'll then be offered the chance to receive the actual NIO752 medicine in an 'open-label' extension phase, where everyone knows they are receiving the active treatment. The total duration of your participation, including the core study and the open-label extension, will be explained fully by the study team. They will also tell you about any follow-up appointments after you stop taking the study medicine.
Potentiella risker och fördelar
Locations (64)
- Mayo Clinic ArizonaVerifierat postnummerScottsdale, USA· Rekrytering
- Univ of California San FranciscoVerifierat postnummerSan Francisco, USA· Rekrytering
- CenExcel Rocky Mtn Klinisk ForskningVerifierat postnummerEnglewood, USA· Rekrytering
- Parkinsons Disease and Movement Disorders Center of Boca RatonVerifierat postnummerBoca Raton, Förenta staterna· Rekrytering
- Mayo JacksonvilleVerifierat postnummerJacksonville, USA· Rekrytering
- University of Kentucky - C201 ClinicVerifierat postnummerLexington, USA· Rekrytering
- Ochsner Clinic FoundationVerifierat postnummerNew Orleans, USA· Rekrytering
- Mayo ClinicVerifierat postnummerRochester, USA· Rekrytering
- Central TX Neuro Consultants P AVerifierat postnummerRound Rock, United States· Rekrytering
- Novartis UndersökningsplatsVerifierat postnummerKogarah, Australia· Rekrytering
- Novartis UndersökningsplatsVerifierat postnummerWestmead, Australien· Rekrytering
- Novartis UndersökningsplatsVerifierat postnummerMelbourne, Australien· Rekrytering
Vanliga frågor
What is Progressive Supranuclear Palsy (PSP)?
PSP is a rare brain condition that causes problems with balance, movement, vision, and speech. It’s a type of parkinsonism, but it’s different from Parkinson’s disease.
What does 'Phase 3 study' mean?
A Phase 3 study means the new medicine has already been tested in smaller groups of people and shown some promise. This is a larger study to confirm if it works well and is safe before it can potentially become available to everyone.
Vad är en 'placebo'?
A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It's used to fairly compare the new medicine's effects against not having the active medicine.
Vad är en 'studiepartner'?
A study partner is a trusted person like a spouse or close friend who knows you well and can help the study team understand your symptoms and how you're doing. They'd need to come to some appointments with you.
Kommer jag att veta om jag får den riktiga medicinen?
Initially, no. For a period, neither you nor your doctor will know if you're getting NIO752 or the placebo. This is called 'double-blind'. After this, everyone will be offered the active medicine in an 'open-label' part of the study.
Hur du får reda på mer
Novartis Läkemedel
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
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Diskussion
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