Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02704390 | Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD | PHASE3 | COMPLETED | 64 | — | — | Jan 1, 2016 | Aug 1, 2019 | Dec 15, 2021 | 3 | Taiwan |
Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores
| Arm | Type | Description |
|---|---|---|
| ORADUR®-Methylphenidate | EXPERIMENTAL | ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 ad...