A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy

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.

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.