PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: AEVI-001; Placebo
Intervention description: Oral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily, during the treatment period.; Oral doses of Placebo will be administered twice daily, during the treatment period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is PART B of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in
      children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes
      implicated in glutamatergic signaling and neuronal activity. PART B will assess subjects who
      do not have CNVs in any of the specific gene mutation(s) implicated in glutamatergic
      signaling and neuronal connectivity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject and parent/legally authorized representative (LAR) can speak English fluently
             and have provided written informed consent, and assent (as applicable) for this study.

          2. Subject is 6 to 17 years of age (inclusive) at the time of consent/assent. The date of
             signature of the informed consent/assent is defined as the beginning of the Screening
             Period. This inclusion criterion will only be assessed at the Screening Visit (Visit
             1).

          3. Subject is male or non-pregnant, non-lactating female, who if of childbearing
             potential agrees to comply with any applicable contraceptive requirements prior to
             administration of investigational product (IP).

          4. Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
             (DSM-5) criteria for a primary diagnosis of ADHD based upon DSM 5 criteria.

          5. Subject has a minimum score of ≥28 on the ADHD-RS-5 at the Baseline Visit (Visit 2).

          6. Subject has been genotyped previously and has their identity confirmed (if required).

        Exclusion Criteria:

          1. Subject or parent/LAR is, in the opinion of the investigator, mentally or legally
             incapacitated, has significant emotional problems at the time of the Screening Visit
             (Visit 1) which could interfere with the conduct of study evaluations.

          2. Subject has a current, controlled or uncontrolled, co-morbid major psychiatric
             diagnosis (aside from ADHD), including an anxiety disorder, major depression, bipolar
             disease, schizophrenia (or any psychotic disorder), and moderate or severe
             intellectual disability. Mild anxiety and/or depressive symptoms that do not meet
             diagnostic criteria for an anxiety disorder or major depression and/or do not require
             treatment are not exclusionary.

          3. Subject has autism spectrum disorder to include a DSM-IV diagnosis of autistic
             disorder, Asperger's disorder, or pervasive developmental disorder.

          4. Subject is currently taking any medication that might confound the results of safety
             assessments conducted in the study.

          5. Subject has a known history of cardiovascular disease, advanced arteriosclerosis,
             structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities,
             coronary artery disease, cardiac conduction problems, exercise-related cardiac events
             including syncope and pre-syncope, or other serious cardiac problems.

          6. Subject has any clinically significant abnormality on 12-lead ECG performed at the
             Screening Visit (Visit 1) and/or the Baseline Visit (Visit 2) such as serious
             arrhythmia, cardiac conduction problems, or other abnormalities deemed to be a
             potential safety issue.