This study is testing a new medicine called SPN-812, or viloxazine, for young children aged 4 to 5 years with ADHD. ADHD, or Attention-Deficit/Hyperactivity Disorder, is a condition that makes it hard to sit still or pay attention. The study will see if the medicine works and if it is safe for these children.
In this study, children will be split into two groups: one group will get the medicine, and the other will get a placebo, a pill with no medicine. Neither the children nor the doctors will know who gets which, making it a "double-blind" study. This helps to make the results fair. The children will be in the study for up to 10 weeks, with 6 weeks of taking the medicine or placebo.
- The study lasts up to 10 weeks, including 6 weeks of treatment.
- Participants must be 4 to 5 years old and have ADHD.
- Participants cannot have a major psychiatric or neurological disorder.
Parents or guardians must agree to the study rules for their child to join. Children with certain health issues or those taking specific medicines cannot participate. Participants will have regular check-ups to see how they are doing.