An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy

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.

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.