A Randomized, Double-blind, Parallel, Placebo-controlled, Flexible-dose Study of ADZENYS XR-ODT™ in Children Aged 4 to Less Than 6 Years Diagnosed with Attention-deficit/Hyperactivity Disorder (ADHD)

Updated on 23 November 2020


The primary objective of this study is to evaluate the efficacy of ADZENYS XR-ODT compared to placebo in the treatment of ADHD symptoms in children aged 4 years to less than 6 years.



Condition Attention Deficit/Hyperactivity Disorder (ADHD - Pediatric)
Clinical Study IdentifierTX218072
Last Modified on23 November 2020


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Inclusion Criteria

Subject has undergone an adequate course of nonpharmacological treatment for ADHD based on investigator judgment or the investigator considers the subject’s condition severe enough to enroll without undergoing prior nonpharmacological treatment
Subjects who have been on a previous pharmacological treatment for ADHD may be enrolled provided they meet other entrance criteria
Subject must have been living with the parent/legal guardian for at least 6 months and no changes in living situation are anticipated for at least 4 months
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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