Safety study of Lisdexamfetamine Dimesylate (LDX) in ADHD
This study is completed in France, in the United Kingdom, in Belgium, .... It is testing Lisdexamfetamine Dimesylate (LDX) for ADHD.
ADHDDrugFrom 6 Years to 17 Years
The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.
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In plain English
Key information made simple
What is this study testing?
This study is testing whether Lisdexamfetamine Dimesylate (LDX) may be useful for adolescents experiencing ADHD.
What would participation involve?
Participants may receive Lisdexamfetamine Dimesylate (LDX), attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Belgium, in France, and in Germany.
Who is it mainly for?
This study appears to be mainly for adolescents 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 placebo, randomization, or a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.
Your next step
Check the study details
Check the official source, then confirm these points with the research team.
Where are visits, can any be remote, and how much time is needed?
Costs and support
What costs, reimbursement or compensation apply?
Before joining
Questions to ask before joining
What are the exact eligibility criteria, and what could exclude someone?
How many visits, assessments, or follow-ups are expected, and over what period?
What risks, side effects, practical burdens, or alternatives should be understood first?
Who should be contacted to confirm locations, timing, compensation, and next steps?
Study clarity
Things to check before joining
Study start dateStarted: November 17, 2008
Recruitment status
Completed
Enrollment listed in the registry
336
Sponsor
Shire
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
France, United Kingdom, Belgium, ...
Age range
From 6 Years to 17 Years
Official registry ID
NCT00763971
Official title
A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Ask HopeStage to help me review this study
This record does not confirm open recruitment. We can help you understand it and explore other studies.
Study ID: NCT00763971. We help you review the study, but cannot decide medical eligibility.
Check recruitment and locations
Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.
Astrid Lindgren Children's Hospital, Karolinska University Hospital
Stockholm
Site status: Not listed — confirm with the team
Barn och Ungdomsmedicin klinik Mölnlycke, Ekdalavägen 2,Box 9
Stockholm
Site status: Not listed — confirm with the team
United Kingdom · 5 sites
Basildon Hospital, Child Developement Centre, Nethermayne
Basildon, Essex
Site status: Not listed — confirm with the team
Lighthouse Child Development Centre, Snakes Lane
Southend-on-Sea, Essex
Site status: Not listed — confirm with the team
Victoria Hospital, Paediatric Unit, Hayfield Road
Kirkcaldy, Fife, Scotland
Site status: Not listed — confirm with the team
Tayside Childrens Hospital, Clinical Research Facility, Level 4
Dundee, Scotland
Site status: Not listed — confirm with the team
Ryegate Children's Centre, Tapton Crescent Road
Sheffield, Yorkshire
Site status: Not listed — confirm with the team
In practice
For you
Participation may contribute to research. Personal benefit is not guaranteed.
Ask the research team to explain the activities, time commitment, and follow-up involved.
Study sites are listed. Confirm the relevant site and any travel before making plans.
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 medication or study treatment 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 involving Lisdexamfetamine Dimesylate (LDX), Methylphenidate Hydrochloride, Placebo. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.
Who might this study be for?
This study may concern people with adhd; age range: From 6 Years to 17 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.
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 Shire, which appears to be unknown or unclear. 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 public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.
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This EU register entry describes an interventional medicine trial, designed to assign participants a study treatment. The protocol sets out the treatment, eligibility criteria and assessments. Check the source details below for country statuses and any transfer to CTIS.
This EU register entry describes an interventional medicine trial, designed to assign participants a study treatment. The protocol sets out the treatment, eligibility criteria and assessments. Check the source details below for country statuses and any transfer to CTIS.
This EU register entry describes an interventional medicine trial, designed to assign participants a study treatment. The protocol sets out the treatment, eligibility criteria and assessments. Check the source details below for country statuses and any transfer to CTIS.
