Efficacy and Safety of SPN-812 ER in Children With ADHD

Inclusion Criteria:

1. Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of
ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM
IV), confirmed with the Mini International Neuropsychiatric Interview for Children
and Adolescents (MINI-KID).

2. ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.

3. CGI-S score of at least 4

4. Weight of at least 20 kg.

5. Free of medication for the treatment of ADHD or any psychosis for at least one week
prior to enrollment.

Exclusion Criteria:

1. Current or lifetime diagnosis of major depressive disorder, bipolar disorder,
personality disorder, Tourette's disorder, or psychosis not otherwise specified.

2. Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive
compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as
primary diagnosis.

3. Significant systemic disease.

4. Evidence of suicidality within the six months before Screening or at Screening.

5. BMI greater than 95th percentile for the appropriate age and gender.

6. Pregnancy or refusal to practice abstinence during the study for female subjects of
childbearing potential (FOCP).

7. Substance or alcohol use during the last three months.

8. Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.