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

Phase 2

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
HLD100 10mg	HLD100	HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg)
HLD100 20mg	HLD100	HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg)
HLD100 30mg	HLD100	HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg)
HLD100 40mg	HLD100	HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg)

Primary Outcome Measures

Name	Time	Method
Dose Escalation to determine optimal dosage for clinical effects	6 weeks	Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner

Secondary Outcome Measures

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