A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

— CEES  

Official title:

A Phase III Clinical Endpoint Evaluation Study Examining the Safety and Efficacy of HLD200 in Pediatric Subjects With Attention-Deficit Hyperactivity Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255513
• Other study ID #: HLD200-106
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Est. completion date: October 2014

Study information

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

Clinical Trial Summary

This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.

Description:

The study consists of two distinct treatment phases. The first is the 6-week open-label, treatment optimization phase during which subjects are titrated to an optimal daily dose of HLD200. Subjects are then randomized to receive either optimal HLD200 or matched placebo treatment for an additional week prior to final testing during a laboratory school day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Male and female children (6-12 years at study entry)

• Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

• Able to swallow treatment capsules

• Available for entire study period

• Provision of informed consent (from the parent[s] and/or legal representative[s]) and assent (from the subject)

• Female subjects of childbearing potential (i.e., post-menarche) required to have a negative result on urine pregnancy test (and will be given specific instructions for avoiding pregnancy during trial).

Exclusion Criteria:

• Any known history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, ophthalmologic disease

• Presence of any significant physical or organ abnormality

• Any illness during the 4 weeks before this study

• Comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder)

• Known history of severe asthma (in the opinion of the investigator) unless deemed currently controlled

• Known history of severe allergic reaction to MPH

• Known history of seizures (except febrile seizures prior to age 5), anorexia nervosa, bulimia or current diagnosis or family history of Tourette's disorder

• Subject who are severely underweight or overweight (in the opinion of the Investigator)

• Any clinical laboratory value outside of the acceptable ranges, unless deemed NCS significant per the Investigator

• Positive history for hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV)

• Positive screening for illicit drug use, and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject

• Use of prescription medications (except ADHD medications) within 7 days and over-the-counter medications (except birth control) within the 3 days preceding study enrollment, unless deemed acceptable by the Investigator and Clinical or Medical Monitor

• Participation in clinical trial with an investigational drug within the 30 days preceding study enrollment

• Current suicidal ideation or history of suicidality determined as a significant finding on the C-SSRS by the investigator (Baseline C-SSRS for adolescents; Pediatric Baseline C-SSRS for children).

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• HLD200

• Placebo

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada
United States	South Shore Psychiatric Services, PC	Marshfield	Massachusetts
United States	AVIDA, Inc.	Newport Beach	California

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	SKAMP	Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Combined Scores - Average of 8:00 am to 4:00 pm assessments from the laboratory school day.; The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 6 sessions occurring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm of the laboratory school day.	8-hours from 8:00 am to 4:00 pm