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A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD (HLD100-103)

Primary Purpose

Attention-Deficit Hyperactivity Disorder (ADHD)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

HLD100

About this trial

This is an interventional treatment trial for Attention-Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Center for Psychiatry and Behavioral Medicine, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

HLD100 10mg

HLD100 20mg

HLD100 30mg

HLD100 40mg

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Safety endpoints include treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG) parameters, physical examination, and the C-SSRS.

Full Information

NCT ID

NCT02884544

First Posted

July 28, 2016

Last Updated

July 15, 2021

Sponsor

Ironshore Pharmaceuticals and Development, Inc

1. Study Identification

Unique Protocol Identification Number

NCT02884544

Brief Title

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

Acronym

HLD100-103

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

August 2016 (Actual)

Primary Completion Date

December 18, 2016 (Actual)

Study Completion Date

December 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ironshore Pharmaceuticals and Development, Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention-Deficit Hyperactivity Disorder (ADHD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HLD100 10mg

Arm Type

Experimental

Arm Description

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

Arm Title

HLD100 20mg

Arm Type

Experimental

Arm Description

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

Arm Title

HLD100 30mg

Arm Type

Experimental

Arm Description

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

Arm Title

HLD100 40mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HLD100

Other Intervention Name(s)

Dextroamphetamine sulfate, delayed release/extended release

Intervention Description

Treatment

Primary Outcome Measure Information:

Title

Dose Escalation to determine optimal dosage for clinical effects

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

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

Description

Safety endpoints include treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG) parameters, physical examination, and the C-SSRS.

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann Childress, MD

Organizational Affiliation

Center for Psychiatry & Behavoural Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Psychiatry and Behavioral Medicine, Inc.

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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