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.
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Locations near you
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Full eligibility criteria for NCT02884544
Ages eligible for Study
6 Years to 12 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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.
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.
All locations for NCT02884544
United States (1)
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
View full eligibility
Tris trial is registered with FDA with number: NCT02884544. The sponsor of the trial is Ironshore Pharmaceuticals and Development, Inc and it is looking for 22 volunteers for the current phase.
Official trial title: 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
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