Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

Overview

The purpose of this study is to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.

Full Title of Study: “An Extension Study to Evaluate the Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2019

Detailed Description

In order to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD, subjects who participated in the previous OP-2PN012-301 study will be invited to join this extension study for 24-month follow-up. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose.

Interventions

  • Drug: ORADUR®-Methylphenidate
    • ORADUR®-Methylphenidate is available in three dosage forms, 22 mg, 33 mg or 44 mg. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose for 24 months.

Arms, Groups and Cohorts

  • Experimental: ORADUR®-Methylphenidate
    • ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months.

Clinical Trial Outcome Measures

Primary Measures

  • SNAP-IV teacher form scores in ORADUR®-Methylphenidate
    • Time Frame: 24 months
    • Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores

Secondary Measures

  • SNAP-IV parent form scores in ORADUR®-Methylphenidate
    • Time Frame: 24 months
    • Change from baseline of SNAP-IV parent form scores
  • Remission rate in ORADUR®-Methylphenidate
    • Time Frame: 24 months
    • Remission rate as assessed by SNAP-IV teacher form and SNAP-IV parent form
  • Conners’ Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate
    • Time Frame: 24 months
    • Change from baseline of Conners’ Continuous Performance Test (CPT-II) performance results
  • Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate
    • Time Frame: 24 months
    • Change from baseline (screening period) of Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis. During study period, DSM-5 diagnosis will be performed at each visit. Investigator will check the diagnostic classification, the dianostic criteria sets and the descriptive test of DSM-5 questionnaire and confirm the severity of ADHD based on subject’s current condition.
  • Clinical Global Impression-ADHD-Severity (CGI-S) scores in ORADUR®-Methylphenidate
    • Time Frame: 24 months
    • Change from baseline of Clinical Global Impression-ADHD-Severity (CGI-S) scores
  • Clinical Global Impression-ADHD-Improvement (CGI-I) scores in ORADUR®-Methylphenidate
    • Time Frame: 24 months
    • Change from baseline of Clinical Global Impression-ADHD-Improvement (CGI-I) scores
  • Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance in ORADUR®-Methylphenidate
    • Time Frame: 24 months
    • Change from baseline of Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance result (at National Taiwan University Hospital, NTUH, only)
  • Treatment compliance in ORADUR®-Methylphenidate
    • Time Frame: 24 months
    • Evaluate the treatment compliance during study period. Compliance will be assessed by the result of drug accountability and presented by the missing dose rate.

Participating in This Clinical Trial

Main Inclusion Criteria:

1. Subjects previously enrolled in OP-2PN012-301 study and completed 4-week study treatment 2. Both subjects and parents/guardians have provided their signed and dated informed consent form for the study Main Exclusion Criteria:

1. Subjects who experienced unmanageable adverse events (AEs) after receiving ORADUR®-Methylphenidate 2. Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI) or other ADHD treatments) that is likely to interfere with safe administration of methylphenidate within 14 day prior to the study treatment initiation 3. Subjects are joining other clinical studies and receiving any other investigational medical products within 14 days prior to the study treatment initiation. 4. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety 5. By the investigators' discretion, subjects cannot understand or follow the instructions given in the study 6. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Orient Pharma Co., Ltd.
  • Collaborator
    • Durect
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shirley Lin, Study Director, Orient pharma

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