This research study is being done by a company, called the “sponsor”, which conducts research studies. The name of the sponsor is Supernus Pharmaceuticals. The drug being studied is called SPN-810. SPN-810 is an “investigational drug”. An Investigational drug means that the drug tested in this study has not been approved by the U.S. Food and Drug Administration (FDA) or any other health authority. The purpose of this study is to find out how well SPN-810 works in reducing impulsive aggressive behaviors in patients with ADHD.
Criteria:
Healthy male or female subjects, age 12-17 years at the time of screening, including outpatients in foster care living at home.
Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) confirmed by MINI-KID.
Monotherapy treatment with an FDA-approved optimized ADHD medication (psychostimulants and non-stimulants for at least one month prior to Screening and willing to maintain the dose throughout the duration of the study.
Retrospective Modified Overt Aggression Scale (R-MOAS) score of ≥ 24 at Screening.
CGI-S score at least moderately ill (≥4) at Screening.
Vitiello Aggression Questionnaire score from -2 to -5 at Screening.
Free of antipsychotic medication for at least 2 weeks or 5x drug’s half-life or whatever is longer prior to Visit 2.
Discontinuation of α2-adrenergic agonists (e.g. clonidine and guanfacine) used for any other reason except for monotherapy treatment of ADHD (e.g. aggression or insomnia) at least two-weeks prior to Visit 2.
Medically healthy with clinically normal laboratory profiles, vital signs and electrocardiograms (ECGs).
Able and willing to swallow tablets whole and not chewed, cut or crushed.
Written informed consent/assent obtained from the subject’s parent or legal authorized representative (LAR), and written informed assent from the subject if required.