Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHD
Condition: ADHD
Intervention: Placebo; 100mg SPN-812; 200mg SPN-812
Intervention description: Placebo was administered once daily; 100mg SPN-812 was administered once daily and compared to placebo; 200mg SPN-812 was administered once daily and compared to placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 477.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of low doses of SPN-812 in children 6-11
      years of age diagnosed with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or female subjects, 6-11 years of age, inclusive.

          2. Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental
             Disorders-5 (DSM-5), confirmed with the Mini International Neuropsychiatric Interview
             for Children and Adolescents (MINI-KID).

          3. Attention Deficit/Hyperactivity Disorder Rating Scale-5, Home Version: Child,
             Investigator Administered and Scored (ADHD-RS-5) score of at least 28.

          4. CGI-S score of at least 4 at screening.

          5. Weight of at least 20 kg.

          6. Free of medication for the treatment of ADHD for at least one week prior to
             randomization and agreement to remain so throughout the study.

          7. Considered medically healthy by the Investigator via assessment of physical
             examination, medical history, clinical laboratory tests, vital signs, and
             electrocardiogram.

          8. Written informed consent obtained from the subject's parent or legal representative
             and informed assent from the subject, if applicable.

          9. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent)
             or, if sexually active, must agree to use one of the following acceptable birth
             control methods beginning 30 days prior to the first dose, throughout the study:

               1. simultaneous use of male condom and intra-uterine contraceptive device placed at
                  least four weeks prior to the first study drug administration

               2. surgically sterile male partner

               3. simultaneous use of male condom and diaphragm with spermicide

               4. established hormonal contraceptive

        Exclusion Criteria:

          1. Current diagnosis of major psychiatric disorders. Subjects with Major Depressive
             Disorder are allowed in the study if the subject is free of episodes both currently
             and for the last six months.

          2. Current diagnosis of major neurological disorders. Subjects with seizures or a history
             of seizure disorder within the immediate family (siblings, parents), or a history of
             seizure-like events are excluded from the study.

          3. Current diagnosis of significant systemic disease.

          4. Evidence of suicidality (defined as either active suicidal plan/intent or active
             suicidal thoughts, or more than one lifetime suicide attempt) within the six months
             before Screening or at Screening.

          5. BMI greater than 95th percentile for the appropriate age and gender.

          6. History of an allergic reaction to viloxazine or related drugs.

          7. Any food allergy, intolerance, restriction or special diet that, in the opinion of the
             Investigator, could contraindicate the subject's participation in this study.

          8. Subjects who received any investigational drug within the longer of 30 days or 5
             half-lives prior to Day 1 dosing of SM.

          9. Any reason, which, in the opinion of the Investigator, would prevent the subject from
             participating in the study.

         10. Positive drug screen at the Screening Visit. A positive test for amphetamines is
             allowed for subjects receiving a stimulant ADHD medication at Screening; the subject
             will be required to discontinue the stimulant for the study, beginning at least one
             week prior to the Baseline Visit.

         11. Pregnancy or refusal to practice abstinence or acceptable birth control during the
             study (for female subjects of childbearing potential).