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| Name | Class |
|---|---|
| Durect | INDUSTRY |
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The purpose of this study is to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORADUR®-Methylphenidate | Experimental | ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORADUR®-Methylphenidate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SNAP-IV teacher form scores in ORADUR®-Methylphenidate | Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| SNAP-IV parent form scores in ORADUR®-Methylphenidate | Change from baseline of SNAP-IV parent form scores | 24 months |
| Remission rate in ORADUR®-Methylphenidate | Remission rate as assessed by SNAP-IV teacher form and SNAP-IV parent form |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirley Lin | Orient pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Medical Foundation- Chiayi Branch | Chiayi City | Taiwan | ||||
| National Taiwan University Hospital |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 24 months |
| Conners' Continuous Performance Test (CPT-II) performance in ORADUR®-Methylphenidate | Change from baseline of Conners' Continuous Performance Test (CPT-II) performance results | 24 months |
| Diagnostic & Statistical Manual for Mental Disorders-Fifth Edition (DSM-5) diagnosis in ORADUR®-Methylphenidate | 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. | 24 months |
| Clinical Global Impression-ADHD-Severity (CGI-S) scores in ORADUR®-Methylphenidate | Change from baseline of Clinical Global Impression-ADHD-Severity (CGI-S) scores | 24 months |
| Clinical Global Impression-ADHD-Improvement (CGI-I) scores in ORADUR®-Methylphenidate | Change from baseline of Clinical Global Impression-ADHD-Improvement (CGI-I) scores | 24 months |
| Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance in ORADUR®-Methylphenidate | Change from baseline of Computerized Cambridge Neuropsychological Test Automated Battery (CANTAB) performance result (at National Taiwan University Hospital, NTUH, only) | 24 months |
| Treatment compliance in ORADUR®-Methylphenidate | Evaluate the treatment compliance during study period. Compliance will be assessed by the result of drug accountability and presented by the missing dose rate. | 24 months |
| Taipei |
| 100 |
| Taiwan |
| Chang Gung Medical Foundation- Linkuo Branch | Taoyuan | Taiwan |