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

July 15, 2021 updated by: Ironshore Pharmaceuticals and Development, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Center for Psychiatry and Behavioral Medicine, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HLD100 10mg
HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg)
Drug: HLD100
Treatment
Other Names:
  • Dextroamphetamine sulfate, delayed release/extended release
EXPERIMENTAL: HLD100 20mg
HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg)
Drug: HLD100
Treatment
Other Names:
  • Dextroamphetamine sulfate, delayed release/extended release
EXPERIMENTAL: HLD100 30mg
HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg)
Drug: HLD100
Treatment
Other Names:
  • Dextroamphetamine sulfate, delayed release/extended release
EXPERIMENTAL: HLD100 40mg
HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg)
Drug: HLD100
Treatment
Other Names:
  • Dextroamphetamine sulfate, delayed release/extended release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ironshore Pharmaceuticals and Development, Inc

Investigators

  • Principal Investigator: Ann Childress, MD, Center for Psychiatry & Behavoural Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

December 18, 2016

Study Completion (ACTUAL)

December 27, 2016

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (ESTIMATE)

August 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLD100-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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