Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: AR11; Placebo
Intervention MeSH terms: Amphetamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; AR11; classroom design; amphetamine sulfate

Summary:

      This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in
      approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will
      enroll to take open-label AR11 BID and undergo dose optimization activities for 8 weeks.
      Patients who achieve a stable dose during the dose optimization period will continue
      participation and will be randomized to take double-blind medication (AR11 or placebo) orally
      twice daily for 1 week. At the end of each double-blind treatment period, patients will be
      evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP
      assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female between 6 and 12 years of age, inclusive, at the time of Screening.

          2. Diagnosed as meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for ADHD.

          3. A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or
             greater.

          4. An ADHD Rating Scale (ADHD-RS) score at Screening and Baseline greater than or equal
             to the 90th percentile normative values for gender and age in at least one of the
             following categories: hyperactive-impulsive subscale, inattentive subscale, or total
             score.

        Exclusion Criteria:

          1. Secondary or co-morbid diagnoses other than ADHD, with the exception of simple
             phobias, oppositional defiant disorder, elimination disorders, motor skills disorders,
             communication disorders, learning disorders, adjustment disorders, and sleep disorders
             if, in the opinion of the investigator, the associated symptoms do not confound
             assessment of safety or efficacy.

          2. Clinically significant cognitive impairment as assessed in the clinical judgment of
             the Investigator.

          3. History of any of the following medical disorders: seizure disorder (excluding a
             history of febrile seizures), structural cardiac disorders, serious cardiac
             conditions, hypertension, untreated thyroid disease, glaucoma, Tourette's disorder, or
             chronic tics.

          4. Clinically significant abnormal ECG finding or abnormal cardiac finding on physical
             exam (including presence of a pathologic murmur) at Screening.

          5. Use of any psychotropic medication (sedative hypnotics prescribed as a sleep aid at a
             stable dose for at least 30 days prior to Baseline, at bedtime only, are allowed
             during the study).

          6. A history of hypersensitivity or intolerance to any formulation of amphetamine or
             lisdexamfetamine.