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.
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 18, 2016
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.
- Drug: HLD100
Arms, Groups and Cohorts
- Experimental: HLD100 10mg
- HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg)
- Experimental: HLD100 20mg
- HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg)
- Experimental: HLD100 30mg
- HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg)
- Experimental: HLD100 40mg
- HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg)
Clinical Trial Outcome Measures
- Dose Escalation to determine optimal dosage for clinical effects
- Time Frame: 6 weeks
- Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner
- Safety (AEs, ECG, laboratory parameters, physical examinations)
- Time Frame: 48 hours
- Safety endpoints include treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG) parameters, physical examination, and the C-SSRS.
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 6 Years
Maximum Age: 12 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Ironshore Pharmaceuticals and Development, Inc
- Provider of Information About this Clinical Study
- Overall Official(s)
- Ann Childress, MD, Principal Investigator, Center for Psychiatry & Behavoural Medicine
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