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Phase I/II Single Center, Open-Label Study Examining Image Result for Pharmacokinetics of 2 Modified-Release Formulations of MPH in Adolescent/Pediatric With ADHD

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ClinicalTrials.gov Identifier: NCT01907360
Recruitment Status : Completed
First Posted : July 24, 2013
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ironshore Pharmaceuticals and Development, Inc

Brief Summary:
This study will be conducted in 2 separate stages, the first in adolescents and the second in children. Both Stages 1 and 2 will use an adaptive, single or multiple cohort open-label, single-treatment, fasting design examining the pharmacokinetic (PK) effects of up to 2 separate modified release (MR) formulations (B and C) of HLD200 (54 mg).

Condition or disease Intervention/treatment Phase
Attention-Deficit Hyperactivity Disorder Drug: B-HLD200 54mg capsules Drug: C-HLD200 54mg capsules Phase 1 Phase 2

Detailed Description:
Both stages of this study will be divided into two phases: Screen and Active Period. During Screen, subjects will be screened over the course of 14 days, and washed off their existing ADHD medication during the final 5 days of outpatient screening. During the active period, subjects will receive a single treatment of B-HLD200 and plasma samples for PK will be collected during the night and through the next 48 hours. In addition, pediatric subjects will undergo math testing using the pen-and-paper PERMP both prior to and post dosing. This study procedure will be carried out across three sequential groups of 6 subjects until the full B-HLD200 formulation cohort of 18 subjects have completed all study procedures. Following the first cohort of 18 subjects, the entire sequence may be repeated in second subject cohort tested with C-HLD200.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Single Center/Treatment Open-Label Adaptive Trial Examining the PK of up to Two Separate HLD200 Modified Release Formulations of Methylphenidate in Adolescent and Pediatric Subjects With Attention-Deficit Hyperactivity Disorder
Study Start Date : August 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adolescents (13-17yrs)
Drug: B-HLD200 54mg capsules (Methylphenidate Modified Release B Formulation) or Drug: C-HLD200 54mg capsules (Methylphenidate Modified Release C Formulation)
Drug: B-HLD200 54mg capsules
Drug: C-HLD200 54mg capsules
Experimental: Children (6-11 yrs)
Drug: B-HLD200 54mg capsules (Methylphenidate Modified Release B Formulation) or Drug: C-HLD200 54mg capsules (Methylphenidate Modified Release C Formulation)
Drug: B-HLD200 54mg capsules
Drug: C-HLD200 54mg capsules



Primary Outcome Measures :
  1. PK [ Time Frame: 48hrs ]
    The primary endpoint is the rate and extent of absorption of MPH utilizing the following parameters: AUC0-tz, AUC0-∞, Cmax, Tmax, absorption lag time, λz, and t1/2elim.


Secondary Outcome Measures :
  1. Safety [ Time Frame: 48hrs ]
    A secondary endpoint will include safety and tolerability and will be assessed by clinical monitoring of blood pressure, pulse rate, laboratory data, suicidality and the reporting of adverse events.



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female adolescents (13-17 years; Stage 1) and children (6-12 years; Stage 2).
  • Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
  • ADHD symptoms controlled on a stable dose of ADHD medication. Subjects should be on MPH or have previous history of symptom control during treatment with MPH.
  • Physical examination free of clinically significant findings, unless deemed NCS by the Investigator and Medical Monitor;
  • 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); and
  • Female subjects of childbearing potential (i.e., post-menarche) required to have a negative result on urine pregnancy testing (and will be given specific instructions on 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, unless deemed NCS by the Investigator and the Medical Monitor;
  • Presence of any significant physical or organ abnormality;
  • Any illness during the 4 weeks before this study, unless deemed NCS by the Investigator and the Clinical and/or Medical Monitor;
  • Severe comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder);
  • Known history of moderate to severe asthma;
  • Known history of severe allergic reaction (including drugs, food, insect bites, environmental allergens);
  • 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.
  • Clinical value outside of the acceptable ranges, unless deemed NCS significant per the Investigator;
  • Positive history for hepatitis B, hepatitis C and 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 and/or Medical Monitor;
  • Blood draws of 50 ml to 249 ml within the 30 days, 250 ml to 449 ml within the 45 days and ≥ 450 ml within the 60 days preceding study enrollment;
  • Participation in clinical trial with an investigational drug within the 30 days preceding study enrollment;
  • Intolerance to venipuncture; and
  • Current suicidal ideation or history of suicidality determined as a significant finding on the Columbia-Suicide Severity Rating Scale (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 ClinicalTrials.gov identifier (NCT number): NCT01907360


Locations
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United States, Nevada
Centre for Psychiatry & Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
Sponsors and Collaborators
Ironshore Pharmaceuticals and Development, Inc
Investigators
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Principal Investigator: Ann Childress, M.D. Centre for Psychiatry & Behavioral Medicine, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ironshore Pharmaceuticals and Development, Inc
ClinicalTrials.gov Identifier: NCT01907360    
Other Study ID Numbers: HLD200-102
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases