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

NCT ID: NCT02884544

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-12-27

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.

Conditions

Attention-Deficit Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLD100 10mg

HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg)

Group Type: EXPERIMENTAL

HLD100

Intervention Type: DRUG

Treatment

HLD100 20mg

HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg)

Group Type: EXPERIMENTAL

HLD100

Intervention Type: DRUG

Treatment

HLD100 30mg

HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg)

Group Type: EXPERIMENTAL

HLD100

Intervention Type: DRUG

Treatment

HLD100 40mg

HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg)

Group Type: EXPERIMENTAL

HLD100

Intervention Type: DRUG

Treatment

Interventions

HLD100

Treatment

Intervention Type: DRUG

Other Intervention Names

Dextroamphetamine sulfate, delayed release/extended release

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ironshore Pharmaceuticals and Development, Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Childress, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Psychiatry & Behavoural Medicine

Locations

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

HLD100-103

Identifier Type: -

Identifier Source: org_study_id