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

Study Overview
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Brief Summary
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This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.

Detailed Description
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The study consists of two distinct treatment phases. The first is the 6-week open-label, treatment optimization phase during which subjects are titrated to an optimal daily dose of HLD200. Subjects are then randomized to receive either optimal HLD200 or matched placebo treatment for an additional week prior to final testing during a laboratory school day.

Official Title
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A Phase III Clinical Endpoint Evaluation Study Examining the Safety and Efficacy of HLD200 in Pediatric Subjects With Attention-Deficit Hyperactivity Disorder.

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: HLD200
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLD200<br>HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening. | Drug: HLD200<br> <br> * Other names: methylphenidate hydrochloride (MPH);|
| Placebo Comparator: Placebo<br>Placebo capsules (dose matched to HLD200 capsules) Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SKAMP | Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Combined Scores - Average of 8:00 am to 4:00 pm assessments from the laboratory school day. The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 6 sessions occurring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm of the laboratory school day. | 8-hours from 8:00 am to 4:00 pm |