MAITLAND - During the pandemic many clinical trials that were not focused on COVID-19 were shut down or stalled. For Dr. Andrea Marraffino, a principal investigator at Accel Research Sites, that meant she couldn’t help hundreds of school aged children in their battle against attention deficit hyperactivity disorder (ADHD).
The restrictions have now been lifted and her clinic at Accel Research Sites is going to have a number of important ADHD trials in the next few weeks and months—including innovative trials involving gamification, those aimed at preschoolers and those aimed at teenagers.
ADHD has affected more than 6 million school aged children across the United States. This can often create high stress for parents looking to find aid for their children. Oftentimes, wait lists for diagnosis of ADHD can be up to a year long, delaying treatment for children and verification needed for schools.
The first study, with Purdue Pharma, is looking for children ages 4 to 12 years old diagnosed with ADHD or who show symptoms of ADHD. The clinical trial will be testing a treatment in children that is already FDA approved for patients 6 years and older. Clinical trial participants will be provided study medication to take once every morning while enrolled. Participation in the trial will last up to 12 months and includes up to 20 in-person visits. The trial is not a placebo-controlled trial, meaning no enrolled participants will receive a placebo drug. Everyone enrolled will receive active study medication. Candidates do not need a previous diagnosis of ADHD.
The second study involves digital therapy in adolescents ages 12 to 17. Through a gaming treatment with Akili Interactive that targets areas of the brain that affect attention, participants learn skills that can help them with prioritizing tasking, ignoring distractions, and multitasking. Participation in the clinical trial lasts up to 3 months and will allow participants to be seen once a month by professionals. Candidates do not need a previous diagnosis of ADHD and can continue current medication treatment for ADHD. Akili Interactive’s treatment is already approved by the FDA for children ages 8 to 12 and was the first treatment option delivered through a video game experience approved by the FDA.
“Our trials help those parents who can often be frustrated by restrictions that need verification from school systems,” said Dr. Andrea Marraffino, lead investigator on these trials. “Our clinical trials allow patients to be evaluated, diagnosed and treated in a fraction of the time it typically can take. Our focus is on the patients and giving parents peace of mind.”
Before studies begin, participates will meet with investigators for a full evaluation and diagnostic assessments. Medication studies also include physical exams, blood tests, and EKGs throughout the course of the study. All study procedures and study medication are provided to participants at no cost. Enrolled participants will be compensated for their time in the trial.
The ADHD clinical trials will take place at the Maitland, FL site. To learn more about the trials and how you can enroll, call (407) 644-1165 or visit https://accelresearchsites.com/.
About Accel Research Sites
Accel Research Sites is a multi-therapeutic network of clinical research sites dedicated to the expert delivery of treatment options to patients and providers. They partner with the most innovative and significant pharmaceutical, biotechnology, and medical device companies worldwide to advance healthcare and wellness in the communities they serve.