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

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: ORADUR®-Methylphenidate

• Registration Number: NCT02704390
• Lead Sponsor: Orient Pharma Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ORADUR®-Methylphenidate	ORADUR®-Methylphenidate	ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SNAP-IV parent form scores in ORADUR®-Methylphenidate	24 months	Change from baseline of SNAP-IV parent form scores
Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate	24 months	Change from baseline of Conners' Continuous Performance Test (CPT-II) performance results
Clinical Global Impression-ADHD-Improvement (CGI-I) scores in ORADUR®-Methylphenidate	24 months	Change from baseline of Clinical Global Impression-ADHD-Improvement (CGI-I) scores
Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate	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.
Treatment compliance in ORADUR®-Methylphenidate	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.
Remission rate in ORADUR®-Methylphenidate	24 months	Remission rate as assessed by SNAP-IV teacher form and SNAP-IV parent form
Clinical Global Impression-ADHD-Severity (CGI-S) scores in ORADUR®-Methylphenidate	24 months	Change from baseline of Clinical Global Impression-ADHD-Severity (CGI-S) scores
Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance in ORADUR®-Methylphenidate	24 months	Change from baseline of Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance result (at National Taiwan University Hospital, NTUH, only)

Trial Locations

Locations (3)

Chang Gung Medical Foundation- Linkuo Branch; 🇨🇳 Taoyuan, Taiwan

Chang Gung Medical Foundation- Chiayi Branch; 🇨🇳 Chiayi City, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan