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

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

Detailed Description
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: ORADUR®-Methylphenidate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORADUR®-Methylphenidate<br>ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months. | Drug: ORADUR®-Methylphenidate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNAP-IV parent form scores in ORADUR®-Methylphenidate | Change from baseline of SNAP-IV parent form scores | 24 months | 
| Remission rate in ORADUR®-Methylphenidate | Remission rate as assessed by SNAP-IV teacher form and SNAP-IV parent form | 24 months | 
| Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate | Change from baseline of Conners' Continuous Performance Test (CPT-II) performance results | 24 months | 
| Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate | 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. | 24 months | 
| Clinical Global Impression-ADHD-Severity (CGI-S) scores in ORADUR®-Methylphenidate | Change from baseline of Clinical Global Impression-ADHD-Severity (CGI-S) scores | 24 months | 
| Clinical Global Impression-ADHD-Improvement (CGI-I) scores in ORADUR®-Methylphenidate | Change from baseline of Clinical Global Impression-ADHD-Improvement (CGI-I) scores | 24 months | 
| Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance in ORADUR®-Methylphenidate | Change from baseline of Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance result (at National Taiwan University Hospital, NTUH, only) | 24 months | 
| Treatment compliance in ORADUR®-Methylphenidate | Evaluate the treatment compliance during study period. Compliance will be assessed by the result of drug accountability and presented by the missing dose rate. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ORADUR®-Methylphenidate