Clinical Trials List
2015-10-01 - 2019-08-31
Phase III
Terminated3
ICD-10F90.1
Attention-deficit hyperactivity disorder, predominantly hyperactive type
ICD-10F90.2
Attention-deficit hyperactivity disorder, combined type
ICD-10F90.8
Attention-deficit hyperactivity disorder, other type
ICD-10F90.9
Attention-deficit hyperactivity disorder, unspecified type
ICD-9314.01
Attention deficit disorder, with hyperactivity
An Extension Study to Evaluate the Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents with ADHD
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Trial Applicant
Orient PHARMA Co., Ltd.
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Sponsor
Orient Pharma Co., Ltd.
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Trial scale
Taiwan Multiple Center
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Update
2025/08/19
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 蔡景淑 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
1. Primary Endpoint:
• Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores
2. Secondary Endpoints:
1) Change from baseline of SNAP-IV parent form scores
2) Remission* rate as assessed by SNAP-IV teacher form and SNAP-IV parent form
*Remission is defined as score ≤ 1 on each item of the first 18 items of SNAP-IV form
3) Change from baseline of Conners’ Continuous Performance Test (CPT-II) performance results
4) Change from baseline of Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis
5) Change from baseline of Clinical Global Impression-ADHD-Severity (CGI-S) scores
6) Change from baseline of Clinical Global Impression-ADHD-Improvement (CGI-I) scores
7) Change from baseline of Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance result (at National Taiwan University Hospital, NTUH, only)
8) Treatment compliance
Inclution 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
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
The Estimated Number of Participants
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Taiwan
50 participants
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Global
0 participants
