A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
This study is a research trial exploring a new medicine called TEV-56286 for adults living with Multiple System Atrophy (MSA). The main goal is to find out if this medicine actually helps treat MSA. Researchers will also look into specific ways the medicine might work and carefully check for any side effects it might cause. Half the people in the study will get the new medicine, while the other half will get a dummy pill (a 'placebo') that looks the same but contains no active medicine. This helps researchers fairly compare the effects. The study will last about 56 weeks for each person, including regular check-ups, and is taking place in several countries.
במבט חטוף
על מה המחקר הזה?
This research study is about a condition called Multiple System Atrophy, or MSA. MSA is a rare and progressive condition that affects the nervous system, leading to problems with movement, balance, and other body functions that we usually don't have to think about, like blood pressure and bladder control. Currently, there's no cure for MSA, and treatments mainly focus on managing symptoms.
Researchers are investigating a new medicine, called TEV-56286, to see if it can help treat MSA. This study is in an early stage (Phase 2), which means it's one of the first times this medicine is being tested in a larger group of people with MSA, after initial safety tests. The main aim is to see if TEV-56286 really makes a difference for people with MSA compared to a dummy medicine (a 'placebo'). They will also be paying close attention to how safe the medicine is and if people can tolerate it well.
Understanding if TEV-56286 is effective and safe could be a very important step towards finding new ways to help people living with MSA. By participating, volunteers contribute to medical knowledge that could benefit many others in the future.
נקודות עיקריות
- This study is testing a new medicine (TEV-56286) for Multiple System Atrophy (MSA).
- It's a 'Phase 2' study, focusing on how well the medicine works and its safety.
- Half of participants will receive the new medicine, and half will receive a dummy pill (placebo).
- Each participant's involvement lasts about 56 weeks with regular check-ups.
- The study takes place in several countries, including the UK.
- Participation helps advance understanding and potential treatments for MSA.
מי עשוי להיות זכאי?
To join this study, doctors need to have already diagnosed you with what they call 'clinically possible' or 'clinically probable' MSA. You also need to be generally stable and healthy, both physically and mentally, according to your medical history and examinations.
There are also some important rules about birth control for both men and women who could potentially have children. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test at the start and use reliable birth control. If you are a man who could father a child, you and your female partner (if she could become pregnant) will also need to use very effective birth control methods throughout the study, unless you have had a vasectomy.
You wouldn't be able to join if you have two or more close family members with MSA, as this might suggest a different condition. You also shouldn't have taken part in another drug study recently. People who have had problems with alcohol or drug abuse in the last year, or are pregnant or breastfeeding, also cannot join. If you're allergic to any part of the study medicine, or are taking certain other medications that might interfere with the study drug, you wouldn't be eligible. There are other specific rules, so it's always best to discuss your full medical history with the study doctor.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Do I have a diagnosis of 'clinically possible' or 'probable' MSA?
- Am I generally healthy and stable, both physically and mentally?
- Have I avoided other drug studies in the last three months?
- Am I not pregnant or breastfeeding?
- Do I have a plan for effective birth control if I or my partner could become pregnant?
- Am I between 30 and 75 years old?
מה כרוך בהשתתפות?
If you decide to take part in this study, you would first go through a screening period for up to 4 weeks to check if you meet all the requirements. Once confirmed, you would then receive either the study medicine (TEV-56286) or a dummy medicine (placebo) for 48 weeks. Neither you nor your study doctor will know which one you are receiving during this time. Throughout this treatment period, you'll have regular visits to the clinic so the study team can monitor your health, check for any side effects, and see how the treatment is working. After the 48 weeks, there will be one final follow-up visit about 4 weeks later. The full study commitment for you, from your first screening visit to your last follow-up, would be about 56 weeks in total. The overall research study itself is expected to run for about 27 months.
סיכונים ותועלות פוטנציאליים
Locations (58)
- Teva Investigational Site 15554מיקוד מאומתלה הויה, ארצות הברית· פעיל אך לא מגייס
- Teva Investigational Site 15545מיקוד מאומתלוס אנג'לס, ארצות הברית· עדיין לא מגייסים
- Teva Investigational Site 15547מיקוד מאומתוושינגטון די.סי., ארצות הברית· פעיל אך לא מגייס
- Teva Investigational Site 15544מיקוד מאומתבוקה רטון, ארצות הברית· פעיל אך לא מגייס
- Teva Investigational Site 15555מיקוד מאומתטמפה, ארצות הברית· פעיל אך לא מגייס
- Teva Investigational Site 15550מיקוד מאומתשיקגו, ארצות הברית· פעיל אך לא מגייס
- Teva Investigational Site 15546מיקוד מאומתקנזס סיטי, ארצות הברית· פעיל אך לא מגייס
- Teva Investigational Site 15736מיקוד מאומתבוסטון, ארצות הברית· פעיל אך לא מגייס
- Teva Investigational Site 15870מיקוד מאומתFarmington Hills, United States· עדיין לא מגייסים
- Teva Investigational Site 15552מיקוד מאומתרוצ'סטר, ארצות הברית· פעיל אך לא מגייס
- Teva Investigational Site 15549מיקוד מאומתניו יורק, ארצות הברית· פעיל אך לא מגייס
- Teva Investigational Site 15551מיקוד מאומתניו יורק, ארצות הברית· פעיל אך לא מגייס
שאלות נפוצות
What is Multiple System Atrophy (MSA)?
MSA is a rare condition that affects the nervous system, leading to problems with movement, balance, and automatic body functions like blood pressure.
What is TEV-56286?
TEV-56286 is a new medicine being tested to see if it can help treat Multiple System Atrophy.
מהו 'פלצבו'?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers fairly compare results.
כמה זמן אהיה במחקר?
Each participant will be in the study for about 56 weeks, which includes screening, treatment, and a follow-up visit.
Can I leave the study early?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your regular medical care.
כיצד לגלות עוד
Teva U.S. Medical Information
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