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

Orient Pharma Co., Ltd.64 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

ORADUR®-MethylphenidateDRUG

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Chang Gung Medical Foundation- Chiayi Branch

Chiayi City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Medical Foundation- Linkuo Branch

Taoyuan, Taiwan

Outcomes

Primary Outcomes

SNAP-IV teacher form scores in ORADUR®-Methylphenidate

Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores

Time frame: 24 months

Secondary Outcomes

SNAP-IV parent form scores in ORADUR®-Methylphenidate

Change from baseline of SNAP-IV parent form scores

Time frame: 24 months

Remission rate in ORADUR®-Methylphenidate

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

Time frame: 24 months

Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate

Change from baseline of Conners' Continuous Performance Test (CPT-II) performance results

Time frame: 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.

Time frame: 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

Time frame: 24 months

Clinical Global Impression-ADHD-Improvement (CGI-I) scores in ORADUR®-Methylphenidate

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.