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double blind PR OROS methylphenidate · 1 trial · 1 indication
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...
OROS methylphenidate is used for attention deficit disorder with hyperactivity (ADHD) in adults. It is an extended-release formulation of methylphenidate, a central nervous system stimulant, designed to provide prolonged symptom control throughout the day.
OROS methylphenidate is developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical research to evaluate the safety and efficacy of this prolonged-release formulation in adult patients with ADHD.
OROS methylphenidate is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 extension study has been completed to assess its safety in adults with ADHD.
OROS methylphenidate has one completed Phase 3 clinical trial, NCT00307684. This open-label, multicenter extension study evaluated the safety of prolonged-release OROS methylphenidate in 155 adults with ADHD across several European countries.
OROS methylphenidate is a specific prolonged-release formulation of methylphenidate. The OROS system delivers the medication gradually over an extended period, which may offer once-daily dosing and more consistent symptom control compared to immediate-release forms.