A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD

Study Overview
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Brief Summary
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The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.

Detailed Description
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This dose-escalation study will examine HLD100 in 24 subjects. The subjects (n=24) will be tested with HLD100 in ascending doses from 10mg up to 40mg. This study will be divided into several phases: Screening, Active Treatment and Follow-Up. All visits have a 2 day window to allow for scheduling.

Official Title
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Phase II, Open-label, Dose-titration, Safety Study Designed to Determine the Evening Dose of a Novel Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) to Produce Optimal Clinical Effects in Children With ADHD

Conditions
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Attention-Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Drug: HLD100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have a diagnosis of ADHD as defined by DSM-5 criteria with confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). Subjects must demonstrate mild-to-moderate impairment of ADHD symptoms and function per the following at screening (V1) and/or baseline (V2): ADHD-RS-IV score at or above the 90th percentile normalized for sex and age in total score and ≥24 at Baseline; CGI-S score ≥4; Subject body weight must be ≥20 kg. Subject must be considered clinically appropriate for treatment with amphetamine and HLD100, including prior treatment experience with an amphetamine product, and ability to swallow treatment capsules. Exclusion Criteria: History of, or current, medical condition or laboratory result which, in the opinion of the investigator, unfavorably alters the risk-benefit of study participation, may jeopardize subject safety, or may interfere with the satisfactory completion of the study and study-related procedures. Serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug. History of seizure disorder (except febrile seizures prior to age 5 and with last occurrence at least 1 year prior to study participation), Tourette's disorder, or intellectual disability of minor severity or greater (DSM-5 criteria). History of psychosis, bipolar disorder, anorexia nervosa, bulimia, or suicide attempt. Current depression, anxiety, conduct/behavior disorder, substance use disorder, or other psychiatric condition which, in the investigator's opinion, may jeopardize subject safety or may interfere with the satisfactory completion of the study and study-related procedures. Active suicidal ideation as evidenced by an ideation score of 2 or greater on the C-SSRS. History of severe allergic reaction or intolerance to amphetamine.

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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLD100 10mg<br>HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg) | Drug: HLD100<br>* Treatment<br>* Other names: Dextroamphetamine sulfate, delayed release/extended release;|
| Experimental: HLD100 20mg<br>HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg) | Drug: HLD100<br>* Treatment<br>* Other names: Dextroamphetamine sulfate, delayed release/extended release;|
| Experimental: HLD100 30mg<br>HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg) | Drug: HLD100<br>* Treatment<br>* Other names: Dextroamphetamine sulfate, delayed release/extended release;|
| Experimental: HLD100 40mg<br>HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg) | Drug: HLD100<br>* Treatment<br>* Other names: Dextroamphetamine sulfate, delayed release/extended release;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Escalation to determine optimal dosage for clinical effects | Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (AEs, ECG, laboratory parameters, physical examinations) | Safety endpoints include treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG) parameters, physical examination, and the C-SSRS. | 48 hours |