THE CLINICAL TRIAL
The primary objective of the Triumph Study was to assess the safety and effectiveness of extended-release capsules in children aged 4 to 12 with attention-deficit/hyperactivity disorder (ADHD). Parents and their children were invited to join the research study if they were either unhappy with their child’s current treatment or if the child was not taking any ADHD medication. The study drug, designed to be taken orally once daily, consisted of multi-layer release beads enclosed within a capsule. The study also aimed to determine the best or optimal dose for each participant.
The clinical trial faced several challenges, primarily due to stigmas associated with an ADHD diagnosis and enrolling children into a clinical research program. We needed to ensure that the study’s identity didn’t label the children as “problems” due to their ADHD symptoms but still communicated its impact, especially on young children. Therefore, our study materials had to emphasize the child’s individuality and potential to engage them and help site staff empower their parents to make well-informed decisions concerning their child’s treatment.