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NCT Number: NCT02704390

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

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

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chang Gung Medical Foundation- Chiayi Branch, Chiayi City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

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

Main Exclusion Criteria:

  • Subjects who experienced unmanageable adverse events (AEs) after receiving ORADUR®-Methylphenidate
  • 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
  • Subjects are joining other clinical studies and receiving any other investigational medical products within 14 days prior to the study treatment initiation.
  • By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety
  • By the investigators' discretion, subjects cannot understand or follow the instructions given in the study
  • Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Treatment and study plan

ORADUR®-Methylphenidate

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. SNAP-IV parent form scores in ORADUR®-Methylphenidate

    Time frame: 24 months

    Change from baseline of SNAP-IV parent form scores

  2. Remission rate in ORADUR®-Methylphenidate

    Time frame: 24 months

    Remission rate as assessed by SNAP-IV teacher form and SNAP-IV parent form

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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)

  8. 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.

Sponsors and collaborators

Lead sponsor

Orient Pharma Co., Ltd.

Industry

Collaborators

  • Durect

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2016
Registry last updated
Dec 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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