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TerminatedNCT04987762

Safety study of Adhansia XR® Extended-Release Capsules in Attention Deficit/Hyperactivity Disorder

This study was terminated in the United States. It is testing Adhansia XR® Extended-Release Capsules for Attention Deficit/Hyperactivity Disorder.

ADHD, Attention Deficit/Hyperactivity DisorderDrugFrom 4 Years to 12 Years
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In plain English

Key information made simple

What is this study testing?

This study is testing whether Safety and Tolerability Study of Adhansia XR may be useful for children experiencing ADHD.

What would participation involve?

Participants may receive Safety and Tolerability Study of Adhansia XR, complete questionnaires or follow-up assessments, attend study visits with the research team. The registry lists locations in the United States.

Who is it mainly for?

This study appears to be mainly for children with ADHD. Because it involves minors, a parent or guardian may need to be involved.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.

What to expect

Your next step

The official record suggests in-person participation through a clinic, with sites including Preferred Research Partners, Inc in Little Rock, MCB Clinical Research Centers, LLC in Colorado Springs, and Clinical Neuroscience Solutions, Inc in Jacksonville. Participation appears to involve a study treatment together with follow-up visits and routine safety or progress checks. The main fit is usually having access to the required digital tools and matching the main diagnosis, while common reasons not to take part include active substance or alcohol problems that could affect the results. This is a later-stage study, which usually means the approach is being followed in broader real-world use.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: August 3, 2021
Recruitment status
Terminated
Estimated enrollment
Not clearly listed
Sponsor
Purdue Pharma LP
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug
Study phase
Not clearly listed
Locations
United States
Age range
From 4 Years to 12 Years
Official registry ID
NCT04987762
Official title
An Open-Label, Multicenter, Multiple-Dose, Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children 4 to 12 Years of Age
Official source
Official registry link

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Study ID: NCT04987762. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular visits and structured follow-up.

Requires travel, with in-person participation in United States.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring digital app or tool for people with adhd. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study. The phase is not clearly listed in the public registry. Phase is mostly relevant for medication studies and some device studies. For this study, it may be more useful to look at what is required, the duration, visits, and eligibility criteria.

Do I need to want to stop or reduce tobacco use to participate?

The public registry appears to mention tobacco, nicotine, alcohol, cannabis, or another addiction-related topic. Ask the study team whether you need to want to stop, reduce, already be abstinent, or simply meet use-related criteria. Eligibility must be confirmed by the study team.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Purdue Pharma LP, which appears to be a pharmaceutical company. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The registry indicates that this study is not currently recruiting. Check the official registry for the reason and latest status.

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