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

NCT02884544 | Completed Phase 2 DMC

• 1 other identifier: HLD100-103
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• Dose Escalation to determine optimal dosage for clinical effects

  Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner

  6 weeks

Secondary Outcomes (1)

• Safety (AEs, ECG, laboratory parameters, physical examinations)

  48 hours

Study Arms (4)

HLD100 10mg

EXPERIMENTAL

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

Drug: HLD100

HLD100 20mg

EXPERIMENTAL

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

Drug: HLD100

HLD100 30mg

EXPERIMENTAL

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

Drug: HLD100

HLD100 40mg

EXPERIMENTAL

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

Drug: HLD100

Interventions

HLD100 DRUG

Treatment

Also known as: Dextroamphetamine sulfate, delayed release/extended release

HLD100 10mg; HLD100 20mg; HLD100 30mg; HLD100 40mg

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ironshore Pharmaceuticals and Development, Inc: lead

Study Sites (1)

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Ann Childress, MD

  Center for Psychiatry & Behavoural Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 31, 2016
• Study Start: August 1, 2016
• Primary Completion: December 18, 2016
• Study Completion: December 27, 2016
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)