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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02255513
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : September 28, 2017
Information provided by (Responsible Party):
Ironshore Pharmaceuticals and Development, Inc

Brief Summary:
This study will examine the efficacy and safety of HLD200 (methylphenidate) in patients age 6-12 years with ADHD. This study has a 6-week dose optimization period followed by a one week double blind randomization assessment.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: HLD200 Drug: Placebo Phase 3

Detailed Description:

Attention-Deficit Hyperactivity Disorder (ADHD) is one of the most common childhood disorders and can continue through adolescence and adulthood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and hyperactivity (over-activity).

This multicenter study will utilize a 6-week open label, treatment optimization phase followed by a double-blind, placebo-controlled, 1-week randomized, parallel-group test period designed to assess the safety and efficacy of HLD200 treatment in pediatric subjects with ADHD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: HLD200 (methylphenidate)
Generic name: Methylphenidate hydrochloride (MPH) Dosage form: Capsules (20,40,60,80,100 mg) Frequency: Once per day during the evening Duration: 7 weeks
Drug: HLD200
methylphenidate hydrochloride (MPH) Capsules
Other Name: methylphenidate

Placebo Comparator: Placebo
Placebo capsules will be filled with microcrystalline cellulose (MCC) beads in place of MPH containing beads found in the HLD200 capsules
Drug: Placebo

Primary Outcome Measures :
  1. Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) combined scores across 8 hours [ Time Frame: 8 weeks ]
    The primary objective is to demonstrate that evening treatment with HLD200 improves control of ADHD symptoms, compared to placebo, throughout the day in pediatric subjects with ADHD. SKAMP combined score from 8 AM to 4 PM (11-19 post dose) will be used.

Secondary Outcome Measures :
  1. Before School Function Questionnaire (BSFQ) total score during early morning [ Time Frame: 8 weeks ]
    BSFQ score from waking until leaving for school

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02255513

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United States, California
Newport Beach, California, United States, 92660
United States, Massachusetts
South Shore Psychiatric Services, PC
Marshfield, Massachusetts, United States, 02050
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Ironshore Pharmaceuticals and Development, Inc
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Principal Investigator: Dr. Ann Childress, M.D. Center for Psychiatry And Behavioral Medicine Inc.
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Responsible Party: Ironshore Pharmaceuticals and Development, Inc Identifier: NCT02255513    
Other Study ID Numbers: HLD200-106
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents