The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder

A multicenter, randomized, double-blind, active- and placebo-controlled, parallel-design
trial.

Inclusion Criteria (Screening):

- Male and female outpatients 18 to 55 years of age, inclusive, at the time of informed
consent.

- Subjects with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th
edition (DSM-5) diagnosis of ADHD (including predominantly inattentive presentation,
hyperactive presentation, and combined presentations) as confirmed by the Adult ADHD
Clinical Diagnostic Scale (ACDS) v 1.2.

- Subjects willing to discontinue all prohibited psychotropic medication starting from
the time of signing the informed consent and up to the 30 (+ 2)-day follow-up period.

Exclusion Criteria:

- Subjects with a history of inadequate response or suboptimal tolerability to
atomoxetine.

- Subjects who report allergies (lifetime treatment history) to stimulant or
nonstimulant ADHD medications.

- Subjects with other DSM-5 disorders including psychosis (current or lifetime), bipolar
disorder (current or lifetime), current major depressive disorder, or current panic
disorder; or another psychiatric diagnosis that the investigator believes is primary
or that will confound efficacy or safety assessments of the trail or interfere with
participation in the trial otherwise.

- Subjects with a clinically significant current DSM-5 diagnosis of borderline,
antisocial, paranoid, schizoid, schizotypal, histrionic, narcissistic, avoidant,
obsessive compulsive, or dependent personality disorders.

- Subjects who currently have clinically significant dermatological, neurological,
hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or
gastrointestinal disorders such as any history of myocardial infarction, congestive
heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or active
or chronic hepatitis B or C.

- Subjects with a history of obstructive sleep apnea.