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

Attention-Deficit Hyperactivity Disorder (ADHD) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884544
• Other study ID #: HLD100-103
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: December 27, 2016

Study information

• Verified date: July 2021
• Source: Ironshore Pharmaceuticals and Development, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 27, 2016
• Est. primary completion date: December 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit Hyperactivity Disorder (ADHD)

Intervention

Drug:
• HLD100
Treatment

Locations

Country	Name	City	State
United States	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Ironshore Pharmaceuticals and Development, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	48 hours