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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HLD200
Placebo
Sponsored by
Ironshore Pharmaceuticals and Development, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

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

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).

Sites / Locations

  • AVIDA, Inc.
  • South Shore Psychiatric Services, PC
  • Center for Psychiatry and Behavioral Medicine, Inc.
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HLD200

Placebo

Arm Description

HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening.

Placebo capsules (dose matched to HLD200 capsules) Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 29, 2014
Last Updated
June 28, 2021
Sponsor
Ironshore Pharmaceuticals and Development, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02255513
Brief Title
A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ironshore Pharmaceuticals and Development, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HLD200
Arm Type
Experimental
Arm Description
HLD200 (methylphenidate hydrochloride) 20, 40, 60, 80, or 100 mg capsules Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to continue their HLD200 treatment over an one week double-blind, placebo-controlled phase. HLD200 was administered orally, once daily each evening.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules (dose matched to HLD200 capsules) Subjects were allowed to titrate to their optimal HLD200 dose during a 6 week open-label, treatment optimization phase before being randomized to receive placebo treatment over a one week double-blind, placebo-controlled phase. Treatments were administered orally, once daily each evening.
Intervention Type
Drug
Intervention Name(s)
HLD200
Other Intervention Name(s)
methylphenidate hydrochloride (MPH)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
SKAMP
Description
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.
Time Frame
8-hours from 8:00 am to 4:00 pm

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Ann Childress, M.D.
Organizational Affiliation
Center for Psychiatry And Behavioral Medicine Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
AVIDA, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
South Shore Psychiatric Services, PC
City
Marshfield
State/Province
Massachusetts
ZIP/Postal Code
02050
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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