Compassionate Use of Domperidone for Refractory Gastroparesis

The following will need to be completed before the investigational treatment can begin:

• Your medical history will be reviewed to make sure domperidone is a safe option for treatment
• You will have a physical examination, including heart and breathing rates, blood pressure, height, weight, and an ECG. An ECG measures the electrical activity of the heart over a period of time. This is a non-invasive procedure and involves attaching sticky pads to your chest and recording your body's electrical activity on a machine. The study doctor/nurse will explain this in more detail to you.
• You will have up to 3 teaspoons of blood drawn through a needle in the arm to make sure it is safe for you to receive domperidone.
• You will have a pregnancy test if you are female.

If your tests results are acceptable, the following will happen to you:

• You will take domperidone 4 times per day. The dose will be calculated by your doctor according to your weight.
• Every two months for the first year, you will have a physical examination, including heart and breathing rates, blood pressure, height, weight, up to 3 teaspoons of blood drawn through a needle in your arm to measure blood levels, and an ECG.
• You will also have an ECG anytime there is an increase in the amount of domperidone you are taking.
• After the first year, if you are benefitting from taking domperidone you will have a physical examination, blood draw and ECG every six months until you stop taking domperidone.