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Also known as OROS*-Methylphenidate
OROS methylphenidate/d · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | JNJ-31001074 1 mg/d 1-mg capsule once daily for 42 days |
| 002 | EXPERIMENTAL | JNJ-31001074 3 mg/d 3-mg capsule once daily for 42 days |
| 003 | EXPERIMENTAL | JNJ-31001074 10 mg/d 10-mg capsule once daily for 42 days |
| 004 | ACTIVE_COMPARATOR | Atomoxetine 80 mg/d 40-mg capsule for 3 days followed by 80-mg capsule once daily for 39 days |
| 005 | ACTIVE_COMPARATOR | OROS methylphenidate HCl 54 mg/d 36-mg capsule for 3 days followed by 54-mg capsule once daily for 39 days |
| 006 | PLACEBO_COMPARATOR | Placebo capsule once daily for 42 days |
| Name | Type | Description |
|---|---|---|
| OROS*-Methylphenidate | DRUG | - |
| Atomoxetine 80 mg/d | DRUG | 40-mg capsule for 3 days, followed by 80-mg capsule once daily for 39 days |
| Placebo | DRUG | Placebo capsule once daily for 42 days |
| OROS methylphenidate HCl 54 mg/d | DRUG | 36-mg capsule for 3 days, followed by 54-mg capsule once daily for 39 days |
| JNJ-31001074 3 mg/d | DRUG | 3-mg capsule once daily for 42 days |
| JNJ-31001074 1 mg/d | DRUG | 1-mg capsule once daily for 42 days |
| JNJ-31001074 10 mg/d | DRUG | 10-mg capsule once daily for 42 days |
Inclusion Criteria: * Patients must be between 6 and 12 years of age inclusive, have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the DSM-IV established through clinical interview by the investigator and corroborated by the SNAP-IV parent rating scale, who in the opi...
OROS-Methylphenidate is an investigational small molecule being studied for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is a long-acting formulation of methylphenidate designed for once-daily dosing. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
OROS-Methylphenidate is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the drug's effectiveness and safety in patients with Attention Deficit Hyperactivity Disorder. The drug is currently in Phase 3 development and remains investigational.
OROS-Methylphenidate is in Phase 3 clinical development for Attention Deficit Hyperactivity Disorder. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. One Phase 3 trial has been completed, and the drug is not currently in active clinical trials.
OROS-Methylphenidate has one completed Phase 3 clinical trial registered as NCT00304681. This study evaluated the effectiveness and safety of CONCERTA (OROS-methylphenidate) compared to immediate-release methylphenidate in children with Attention Deficit Hyperactivity Disorder. The trial enrolled 147 participants aged 6 years and older.
OROS-Methylphenidate works by targeting the reuptake of dopamine and norepinephrine in the brain, increasing their concentrations in the synaptic cleft. This mechanism helps improve attention and reduce hyperactivity and impulsivity in patients with Attention Deficit Hyperactivity Disorder. The OROS delivery system provides extended release of the medication.
Yes, OROS-Methylphenidate is the same as CONCERTA, as indicated in the clinical trial title. CONCERTA is the brand name for the OROS formulation of methylphenidate. The drug is being developed by Johnson & Johnson for the treatment of Attention Deficit Hyperactivity Disorder.