NCT02704390CompletedPhase 3
An Extension Study to Evaluate the Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Orient Pharma Co., Ltd.
- Enrollment
- 64
- Locations
- 3
- Primary Endpoint
- SNAP-IV teacher form scores in ORADUR®-Methylphenidate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
ORADUR®-Methylphenidate
Experimental
ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months.
Intervention: ORADUR®-Methylphenidate (Drug)
Outcomes
Primary Outcomes
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
- SNAP-IV parent form scores in ORADUR®-Methylphenidate(24 months)
- Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate(24 months)
- Clinical Global Impression-ADHD-Improvement (CGI-I) scores in ORADUR®-Methylphenidate(24 months)
- Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate(24 months)
- Treatment compliance in ORADUR®-Methylphenidate(24 months)
- Remission rate in ORADUR®-Methylphenidate(24 months)
- Clinical Global Impression-ADHD-Severity (CGI-S) scores in ORADUR®-Methylphenidate(24 months)
- Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance in ORADUR®-Methylphenidate(24 months)
Investigators
Study Sites (3)
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