Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A Phase 4, Multicenter, 2-part Study Composed of a Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-comparator, Dose-optimization Evaluation followed by a Open-label Evaluation to Assess the Safety and Efficacy of Guanfacine Hydrochloride Prolonged-release (SPD503) in Children and Adolescents aged 6 to 17 Years with Attention-deficit/Hyperactivity Disorder

This study is for children and teenagers aged 6 to 17 who have Attention-Deficit/Hyperactivity Disorder (ADHD). We are looking at a medicine called Intuniv (also known as guanfacine hydrochloride prolonged-release) to see how well it works and if it's safe. We compare different doses of Intuniv with another ADHD medicine called atomoxetine, and with a dummy pill (placebo). This helps us understand the best way to use Intuniv. The study is split into two parts: first, a careful comparison where some people get Intuniv, some get atomoxetine, and some get a dummy pill, without anyone knowing who gets what. Then, there's an open-label part where everyone knows they are getting Intuniv.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Takeda Development Center Americas Inc.

Enrolment target

Start

25 Apr 2023

Attention-deficit/hyperactivity disorder (ADHD)

What is this study about?

This study is looking at a medicine called Intuniv, which is already used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and teenagers. ADHD can make it hard to focus, be still, and think before acting. Medicines like Intuniv can help manage these symptoms.

The main goal of this particular study is to learn more about how safe and effective Intuniv is in children and teenagers aged 6 to 17. We want to find out the best dose to use and compare it with another common ADHD medicine, atomoxetine, and also with a 'placebo' (a dummy pill that looks like the medication but has no active ingredients). This careful comparison helps us understand the true effects of Intuniv.

This is a 'Phase 4' study, which means the medicine is already approved and available. These types of studies help us gather even more information about a medicine's long-term safety and how well it works in real-world situations, making sure we have the clearest picture possible for doctors and families.

Key takeaways

This study is for children and teenagers (6-17) with ADHD.
It compares Intuniv with another medicine and a dummy pill.
The aim is to find the safest and most effective dose of Intuniv.
Participation involves regular clinic visits and assessments.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to children and teenagers of all genders who are between 6 and 17 years old and have been diagnosed with ADHD.

There might be other specific health requirements or conditions that would mean someone could or could not join the study. These are important for safety and to make sure the study results are clear.

If you are interested, a study doctor would talk with you and your child to figure out if they meet all the necessary requirements to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child between 6 and 17 years old?
Does my child have a diagnosis of ADHD?
Is my child healthy enough to take part in a study?
Am I, as a parent or guardian, willing to commit to regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you or your child decides to take part, the study will involve several visits to a clinic. You or your child might receive Intuniv at different doses, another ADHD medicine called atomoxetine, or a dummy pill. Neither you nor your study doctor will know which treatment is being given during the first part of the study; this is called 'double-blind'.

There will be regular assessments, which include things like checking their heart rate, blood pressure, weight, and height. They might also complete questionnaires about their ADHD symptoms and how they are feeling, and do some tasks on a computer or tablet that look at things like attention and reaction time. These assessments help the study team understand how the medicine is working and if there are any side effects.

After the first comparison part, there will be an 'open-label' part, where everyone will know they are receiving Intuniv. The total duration of the study will involve several months of treatment and follow-up appointments.

Potential risks and benefits

Taking part in any study has potential benefits and potential risks. A possible benefit is that your child might find a treatment that helps manage their ADHD symptoms effectively. You'll also be closely monitored by a healthcare team. However, there's a chance the medicine might not work for your child, or they might experience side effects. These could include feeling sleepy, tired, or dizzy, or changes in heart rate or blood pressure. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden
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Unverified
Netherlands
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Unverified
Spain
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Unverified
Belgium
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Unverified
Germany

Common questions

What is ADHD?

ADHD stands for Attention-Deficit/Hyperactivity Disorder. It's a condition that can make it hard for someone to pay attention, control impulsive behaviours, or be overly active.

What is Intuniv?

Intuniv is a medicine that helps manage ADHD symptoms. It's a prolonged-release tablet, meaning it releases the medicine slowly over time.

What does 'double-blind' mean?

In a 'double-blind' study, neither the patient nor the doctor knows whether the patient is getting the active medicine or a dummy pill (placebo). This helps make sure the results are fair and unbiased.

What is a 'Phase 4' study?

A 'Phase 4' study looks at a medicine that's already approved and available. It helps gather more information about its safety and how well it works in a larger number of people over a longer time.

Will my child get the actual medicine or a dummy pill?

During the first part of the study, your child will be randomly assigned to receive Intuniv, another ADHD medicine (atomoxetine), or a dummy pill. Neither you nor the study team will know which one.