KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD
Condition: ADHD
Intervention: KP415 oral capsule
Intervention description: Once-daily oral dose
Intervention MeSH terms: Serdexmethylphenidate and dexmethylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 282.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This study is a multicenter, dose-optimized, open-label safety study with KP415 in children
      with Attention-Deficit/Hyperactivity Disorder (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth
             Edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or
             hyperactive/impulsive presentation) per clinical evaluation and confirmed by the Mini
             International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).

          2. Subject must have a score of at least 3 (mildly ill) on the clinician-administered
             Clinical Global Impressions-Severity (CGI-S) scale.

          3. Subjects who completed the efficacy study with KP415 may be rolled over into the
             current study.

          4. Subject, subject's parent/legal guardian and caregiver (if applicable) must understand
             and be willing and able to comply with all study procedures and visit schedule.

        Exclusion Criteria:

          1. Subject with any clinically significant chronic medical condition that may interfere
             with the participant's ability to participate in the study.

          2. Subject has any diagnosis of bipolar I or II disorder, major depressive disorder,
             conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism
             spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual
             disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or
             behavioral disturbances.

          3. Subject has evidence of any chronic disease of the central nervous system (CNS) such
             as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related
             disorders that might occur in childhood, or history of persistent neurological
             symptoms attributable to serious head injury.

          4. Subject has a current (last month) psychiatric diagnosis other than specific phobia,
             motor skills disorders, oppositional defiant disorder, sleep disorders, elimination
             disorders, adjustment disorders, learning disorders, or communication disorders.
             Participants with school phobia or separation anxiety will not be eligible.

          5. Subject has clinically significant suicidal ideation/behavior, based on a history of
             attempted suicide and the C-SSRS assessment at Screening or at any time before the
             last dose of study drug.

          6. Subject has any clinically significant unstable medical abnormality, chronic disease,
             or a history of a clinically significant abnormality of the cardiovascular,
             gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of
             a condition that may interfere with drug absorption, distribution, metabolism, or
             excretion of study drug.

          7. Subject has a history or presence of abnormal ECGs.