An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy
This research study, called an extension trial, is looking at a medicine named TEV-56286 for people living with Multiple System Atrophy (MSA). The main goal is to understand how safe this medicine is over a long time when taken by mouth, and if patients can tolerate it well. Researchers will also be looking closely at any side effects. This study is for adults and will last for about 100 weeks, which is nearly two years. It's building on information learned from a previous part of the study. If you have MSA and have been in the earlier trial, you might be able to join this one.
एक नजर में
यह अध्ययन किस बारे में है?
This study is a continuation of earlier research into a new medicine called TEV-56286. It's specifically designed for people who have Multiple System Atrophy (MSA). MSA is a serious condition that affects the nervous system, impacting movement, balance, and other body functions.
The main aim of this particular study is to see how safe this new medicine is for people to take over a longer period. The researchers want to understand if it causes any unwanted side effects and how well people can tolerate taking it every day. By looking at long-term safety, they can get a better picture of the medicine's potential use.
This study is also a chance to gather more information about how the medicine works and if it helps with the symptoms of MSA. It's an important step in researching new treatments for this condition. The study will last for quite a while, about 100 weeks, to make sure they collect thorough information about the medicine's effects over time.
मुख्य निष्कर्ष
- This study is for people with Multiple System Atrophy (MSA).
- It's an extension of a previous trial, focusing on long-term safety.
- The new medicine being tested is called TEV-56286.
- Participation lasts for about 100 weeks (nearly two years).
- You must have completed the earlier part of the trial to join.
- Careful monitoring of health and side effects is part of the study.
कौन पात्र हो सकता है?
To join this study, you must have already taken part in the previous clinical trial for TEV-56286 (called TV56286-NDG-20039) and completed it successfully. This means you finished all your appointments and followed the study rules up to the 48-week visit.
For women who could become pregnant, you'll need to have a negative pregnancy test at the start of this study. If you or your male partner could have children, you'll need to use very effective birth control throughout the study and for 28 days after your last dose of the study medicine.
You cannot join if you are pregnant, planning to become pregnant, or breastfeeding. Also, if you are currently taking any medicines that are not allowed in this study, you would not be able to participate. There are some other reasons people might not be able to join, so your doctor will check all the details carefully.
क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?
यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.
- Did I complete the previous TEV-56286 study (TV56286-NDG-20039)?
- Am I an adult aged 30 or older?
- Am I pregnant or planning to be, or am I breastfeeding?
- Am I taking any medicines that my doctor has told me might not be allowed in the study?
भागीदारी में क्या शामिल है?
If you join this study, you will continue to take the study medicine, TEV-56286, by mouth. The study involves regular visits to the clinic so the research team can monitor your health, check for any side effects, and see how you are tolerating the medicine. These visits will also involve assessments to understand how your condition is progressing and if the medicine is having any effect.
The research team will provide you with detailed information about the schedule of visits and what will happen at each one. You'll have regular check-ups, potentially including blood tests, physical examinations, and questionnaires about your symptoms and how you're feeling. The total duration for your involvement in the study will be about 100 weeks, which is just under two years, but you will be closely supported throughout this time.
संभावित जोखिम और लाभ
स्थान (26)
- Teva Investigational Site 15554सत्यापित पोस्टकोडला जोला, संयुक्त राज्य अमेरिका· भर्ती
- Teva Investigational Site 15544सत्यापित पोस्टकोडबोका रैटन, संयुक्त राज्य अमेरिका· भर्ती
- Teva Investigational Site 15555सत्यापित पोस्टकोडटाम्पा, संयुक्त राज्य अमेरिका· भर्ती
- Teva Investigational Site 15549सत्यापित पोस्टकोडन्यूयॉर्क, संयुक्त राज्य अमेरिका· भर्ती
- Teva Investigational Site 15551सत्यापित पोस्टकोडन्यूयॉर्क, संयुक्त राज्य अमेरिका· भर्ती
- Teva Investigational Site 15543सत्यापित पोस्टकोडस्पोकेन, संयुक्त राज्य अमेरिका· भर्ती
- Teva Investigational Site 35290सत्यापित पोस्टकोडबोर्दो, फ्रांस· भर्ती
- Teva Investigational Site 35291सत्यापित पोस्टकोडपेरिस, फ्रांस· भर्ती
- Teva Investigational Site 35292सत्यापित पोस्टकोडटूलूज़, फ्रांस· भर्ती
- Teva Investigational Site 32818सत्यापित पोस्टकोडड्रेसडेन, जर्मनी· भर्ती
- Teva Investigational Site 32822सत्यापित पोस्टकोडडसेलडॉर्फ, जर्मनी· भर्ती
- Teva Investigational Site 32825सत्यापित पोस्टकोडKassel, Germany· भर्ती
सामान्य प्रश्न
What is Multiple System Atrophy (MSA)?
MSA is a rare condition that causes damage to nerve cells in the brain, affecting movement, balance, and automatic body functions like blood pressure.
What is TEV-56286?
TEV-56286 is an experimental medicine being tested to see if it can help people with MSA. It's not yet approved for general use.
How long will this study last?
The study is planned to last for about 100 weeks, which is nearly two years.
क्या मुझे अध्ययन में शामिल होने के लिए भुगतान करना होगा?
No, you will not have to pay to participate in the study. The study medicine and assessments are covered by the research.
अगर मैं अपना मन बदल लूँ तो क्या मैं अध्ययन छोड़ सकता हूँ?
Yes, you can leave the study at any time, for any reason. Your decision will not affect your future medical care.
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