A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD

Attention-Deficit Hyperactivity Disorder (ADHD) is one of the most common childhood disorders
and can continue through adolescence and adulthood. Symptoms include difficulty staying
focused and paying attention, difficulty controlling behavior and hyperactivity
(over-activity).

This multicenter study will utilize a 6-week open label, treatment optimization phase
followed by a double-blind, placebo-controlled, 1-week randomized, parallel-group test period
designed to assess the safety and efficacy of HLD200 treatment in pediatric subjects with
ADHD.

Inclusion Criteria:

- Male and female children (6-12 years at study entry)

- Previous diagnosis of ADHD and confirmation using the Mini International
Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

- Able to swallow treatment capsules

- Available for entire study period

- Provision of informed consent (from the parent[s] and/or legal representative[s]) and
assent (from the subject)

- Female subjects of childbearing potential (i.e., post-menarche) required to have a
negative result on urine pregnancy test (and will be given specific instructions for
avoiding pregnancy during trial).

Exclusion Criteria:

- Any known history or presence of significant cardiovascular, pulmonary, hepatic,
renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,
neurologic, ophthalmologic disease

- Presence of any significant physical or organ abnormality

- Any illness during the 4 weeks before this study

- Comorbid psychiatric diagnosis that may affect subject safety or confound results
(e.g., psychosis, bipolar disorder)

- Known history of severe asthma (in the opinion of the investigator) unless deemed
currently controlled

- Known history of severe allergic reaction to MPH

- Known history of seizures (except febrile seizures prior to age 5), anorexia nervosa,
bulimia or current diagnosis or family history of Tourette's disorder

- Subject who are severely underweight or overweight (in the opinion of the
Investigator)

- Any clinical laboratory value outside of the acceptable ranges, unless deemed NCS
significant per the Investigator

- Positive history for hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV)

- Positive screening for illicit drug use, and/or current health conditions or use of
medications that might confound the results of the study or increase risk to the
subject

- Use of prescription medications (except ADHD medications) within 7 days and
over-the-counter medications (except birth control) within the 3 days preceding study
enrollment, unless deemed acceptable by the Investigator and Clinical or Medical
Monitor

- Participation in clinical trial with an investigational drug within the 30 days
preceding study enrollment

- Current suicidal ideation or history of suicidality determined as a significant
finding on the C-SSRS by the investigator (Baseline C-SSRS for adolescents; Pediatric
Baseline C-SSRS for children).