About the LEAGUE Study

About the study icon

What is the LEAGUE Study all about?

The LEAGUE Study is looking at an investigational drug for attention-deficit/hyperactivity disorder, better known as ADHD. Participants will be in the study for about 1.5 to 2 years, depending on which treatment group they are in.

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Why is the LEAGUE Study being conducted?

For many decades, a type of treatment called stimulants have been used to treat ADHD. However, stimulants are not suitable for everybody, either due to problems with side effects or because they are not effective in certain people.

More recently, nonstimulant medications have been developed which have shown benefits in treating the symptoms of ADHD.

The investigational drug being evaluated in the LEAGUE Study is a nonstimulant but has a different mechanism of action to previous ADHD treatments. This means that it works along a different pathway in the body, so we are studying it to see if it may help people with ADHD who have found other treatments ineffective, or who cannot take them due to side effects.

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Who can take part in the study?

The LEAGUE Study will involve children and teenagers–aged 6 to 17 years of age– diagnosed with ADHD.

Anyone who is interested in taking part will have their health and medical history thoroughly checked to make sure they meet all the requirements.

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What can we expect from the LEAGUE Study?

If your child meets the study requirements and is enrolled, they will be randomly selected to receive one of three treatments: the investigational drug, another ADHD drug (referred to as the 'comparator study drug'), or placebo. You won’t be able to choose which drug your child receives. In fact, no-one involved with the study–you, your child, the study doctors or study staff–will know who gets which treatment; however, the doctor can find out if there is an emergency.

What is a placebo?
  • A placebo looks exactly like the study medication but contains no active ingredient.
  • Many clinical studies include a placebo.
  • The placebo group helps the researchers determine if any effects seen during the study are caused by the study drug, or by something else.

The study drugs will be taken by mouth once a day, every day, at the same time each morning. The placebo will look identical to the study drugs and will be taken the same way.

The study drugs and placebo must be taken whole and should not be crushed, chewed, or broken before being swallowed. It is therefore important that your child is able to swallow whole tablets. You will be given full instructions on how and when your child will need to take the study drugs.

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Why will one group take another drug for ADHD?

We need one group of participants to take another drug approved for ADHD so we can compare the effects.

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What happens next?

After the first 18 weeks of the LEAGUE Study (known as Study Part A), eligible participants who have been receiving placebo will be switched to the investigational drug for 1 year (this part of the study will be known as Study Part B).

After 18 weeks in Study Part A:
  • The other two groups (those who have been receiving the investigational drug or the comparator study drug), will continue to receive the same treatment for the remainder of 1 year.
  • After this time, all participants from these two groups will receive the investigational drug for another year (Study Part B).

Part B of the study is known as the open-label stage, because everyone knows that they are taking the investigational drug

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What sort of assessments will be carried out during the LEAGUE Study?

Your child’s health will be carefully monitored throughout the study. You and your child will attend study visits, approximately every 4 weeks, where the study team can check your child’s physical health. There will also be some questionnaires to complete, and some tasks for your child to perform, which will help us note any changes in behavior, and also assess how your child processes information by looking at their attention span and what they can remember, and how your child is getting on in terms of their ADHD symptoms.

The health checks will include some ECGs to assess the health of your child’s heart. These ECGs will be done before your child starts the study drug, and again later in the study. Your child will also have some blood tests.

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Are there any risks in taking part?

Taking any medication always carries a potential risk of side effects. You will be informed about all known side effects associated with the study drugs before deciding whether you want your child to take part in the study.

Your child will be monitored closely throughout the LEAGUE Study, and you should contact the study team immediately if you notice any changes to their health.

We encourage you to discuss the LEAGUE Study with your doctor.

Answer a few questions to see if your child may qualify for the LEAGUE study.