The study medication, called CIN-102 or deudomperidone, is a new form of domperidone. Domperidone is used in many countries outside of the United States for symptoms of diabetic gastroparesis. Unfortunately, domperidone can have serious side effects, so it is not approved for use in the United States but can be used under a special agreement between a physician and the Food and Drug Administration.
Deudomperidone is made by slightly changing domperidone. It is expected to have similar benefits with fewer side effects. However, more research is needed.
Participants will be assigned at random (like the flip of a coin) to receive either the study medication (CIN-102) or placebo (no active ingredients)
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration(FDA), and it can only be used in clinical research studies like the envision 3D study.