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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00307684 | Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) | PHASE3 | COMPLETED | 155 | — | — | Jan 1, 2006 | Jul 1, 2008 | Apr 21, 2014 | 21 | France, Germany +5 |
To evaluate the long term safety and tolerability of PR OROS MPH (18, 36, 54, 72 and 90 mg/day) in adults with Attention Deficit Hyperactivity Disorder (ADHD)
To evaluate maintenance of treatment effects of PR OROS MPH vs. placebo as measured on CAARS. CAARS assesses ADHD symptoms and behaviors in adults. best value: 0 worst value: 54 Endpoint: last available post-baseline assessment.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | open label PR OROS methylphenidate Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany) |
| 002 | EXPERIMENTAL | double blind PR OROS methylphenidate 18 36 54 72 or 90 mg/day once daily for 4 weeks |
| 003 | PLACEBO_COMPARATOR | double blind placebo matching placebo tablets once daily for 4 weeks |
| Name | Type | Description |
|---|---|---|
| double blind placebo | DRUG | matching placebo tablets once daily for 4 weeks |
| double blind PR OROS methylphenidate | DRUG | 18, 36, 54,72 or 90 mg/day once daily for 4 weeks |
| open label PR OROS methylphenidate | DRUG | Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany) |
Inclusion Criteria: * Patient has completed study CR002479 (42603ATT3002), according to protocol * Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)1 and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM IV (CAADID) * He...