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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/d is used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is an oral small molecule therapy studied in both children and adults with ADHD. Johnson & Johnson developed it, and the clinical program includes placebo-controlled, double-blind trials in ADHD patients.
OROS methylphenidate/d is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical trials evaluating the therapy in Attention Deficit Hyperactivity Disorder, including studies in adults and in children with ADHD.
OROS methylphenidate/d has reached Phase 3 clinical development for Attention Deficit Hyperactivity Disorder. Two trials in the program are completed, and none are currently active. The Phase 3 study, NCT00304681, compared CONCERTA with immediate release methylphenidate in children with ADHD.
OROS methylphenidate/d has been studied in two completed trials: NCT00880217, a Phase 2 dose-evaluation study of JNJ-31001074 in 430 adults with ADHD, and NCT00304681, a Phase 3 study comparing CONCERTA with immediate release methylphenidate in 147 children with ADHD. Both were randomized, double-blind, and placebo-controlled.
The OROS methylphenidate/d clinical program enrolled 577 patients across two completed trials. NCT00880217 enrolled 430 adults with ADHD in the United States, and NCT00304681 enrolled 147 children with ADHD. Both studies used randomized, double-blind, placebo-controlled designs.