Attention-Deficit Hyperactivity Disorder (ADHD)
Conditions
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.
Interventions
DRUGHLD100
Treatment
Sponsors
Ironshore Pharmaceuticals and Development, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed