Clinical trial NCT02704390: Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
Official title: An Extension Study to Evaluate the Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ORADUR®-Methylphenidate
Lead sponsor: Orient Pharma Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Durect
First posted: 2016-03-10
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: SNAP-IV teacher form scores in ORADUR®-Methylphenidate
timeFrame: 24 months
Secondary outcomes:
measure: SNAP-IV parent form scores in ORADUR®-Methylphenidate
timeFrame: 24 months
measure: Remission rate in ORADUR®-Methylphenidate
timeFrame: 24 months
measure: Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate
timeFrame: 24 months
measure: Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate
timeFrame: 24 months
measure: Clinical Global Impression-ADHD-Severity (CGI-S) scores in ORADUR®-Methylphenidate
timeFrame: 24 months
measure: Clinical Global Impression-ADHD-Improvement (CGI-I) scores in ORADUR®-Methylphenidate
timeFrame: 24 months
measure: Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance in ORADUR®-Methylphenidate
timeFrame: 24 months
measure: Treatment compliance in ORADUR®-Methylphenidate
timeFrame: 24 months
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chang Gung Medical Foundation- Chiayi Branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation- Linkuo Branch
Study officials:
affiliation: Orient pharma
name: Shirley Lin
role: STUDY_DIRECTOR
References: