A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD
Status:
Unknown status
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is
designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD.
Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD
(combined, inattentive or hyperactive/impulsive) will be enrolled.
There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include
washout if applicable, an enrollment & parent training phase lasting 2-4 weeks, an
eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a
6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR®
responders, and a two-week follow-up call after study completion or early discontinuation to
assess for ongoing adverse events and concomitant medications.
Up to 150 subjects will be enrolled in this trial to allow for subjects who improve
significantly during the behavior training phase and drop-outs. Once 74 subjects have
completed the double-blind phase, no additional subjects will be enrolled in the trial.
Subjects who are already enrolled at that time will be allowed to complete the trial.
The primary objective of this study is to establish that an optimal dose of Aptensio XR® will
result in a significant reduction in ADHD symptoms compared with placebo in children ages 4
to under 6 years