Clinical Trials / Research Studies

Clinical Trials / Research Studies

What will happen in the study?

This study involves participation over 1.5 to 2 years (18 study visits for Part A and 16 visits for part B), with the screening period lasting up to 35 days. During the first visit, the study doctor will perform the following procedures to determine if your child is able to take part in this study:

You will:

• Be asked about your child’s medical and/or mental health history.
• Be asked about your child’s medications or treatments, and specifically about possible prior stimulant therapy.

Your child will:

• Have a full physical exam.
• Have an electrocardiogram (ECG) to measure the electrical activity of their heart.
• Submit urine and blood samples.
• Be asked to perform tasks.

If your child is eligible and you and your child decide to participate in the study, you will be given instructions about how to gradually stop your child’s ongoing medications (called a washout period) before your child enters the study. The study will be divided into 2 parts:

Part A

Your child will be assigned to 1 of 3 treatment groups randomly (like pulling a name from a hat):

• Group 1: participants will take guanfacine tablets and placebo capsules.
• Group 2: participants will take atomoxetine capsules and placebo tablets.
• Group 3: participants will take placebo tablets and placebo capsules.

Neither you nor your child’s study doctor will know which study medications your child is taking while he/she is in Part A of this research study. If your child’s study doctor needs to know because of a medical emergency, he/she can find out.

Part B

If your child completes Part A, he/she may be eligible to enter Part B. The study doctor will check if this is right for your child. In this part, all participants will take guanfacine for a period of 1 year. Both you and your child’s study doctor will know your child is taking guanfacine during this period.

In both Parts A and B, the study doctor will aim to find the right dose of study medication that will provide the most potential benefits and the fewest side effects for your child.

You and your child will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.