Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ORADUR®-Methylphenidate
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.
Interventions
DRUGORADUR®-Methylphenidate
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.
Sponsors
Durect
Orient Pharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| SNAP-IV parent form scores in ORADUR®-Methylphenidate | 24 months | Change from baseline of SNAP-IV parent form scores |
| Remission rate in ORADUR®-Methylphenidate | 24 months | Remission rate as assessed by SNAP-IV teacher form and SNAP-IV parent form |
| Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate | 24 months | Change from baseline of Conners' Continuous Performance Test (CPT-II) performance results |
| 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. |
| 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 |
| 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) |
| 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. |
| 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 |
Countries
Taiwan
Outcome results
None listed