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prolonged release OROS methylphenidate · 1 trial · 1 indication
The primary endpoint was the change in the ADHD symptoms total score of the investigator-rated CAARS from baseline to the last assessment in the double-blind treatment period. CAARS assesses ADHD symptoms and behaviors in adults using a scale ranging from 0 (best) to 54 (worst). For subjects without a post-baseline efficacy measurement, a change of 0 units was imputed.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | prolonged release (PR) OROS methylphenidate 54 mg 18+36mg once daily for 13 weeks |
| 002 | EXPERIMENTAL | prolonged release (PR) OROS methylphenidate 72 mg 2x36mg once daily for 13 weeks |
| 003 | PLACEBO_COMPARATOR | Placebo 2xplacebo once daily for 13 weeks |
| Name | Type | Description |
|---|---|---|
| prolonged release (PR) OROS methylphenidate 54 mg | DRUG | 18+36mg once daily for 13 weeks |
| prolonged release (PR) OROS methylphenidate 72 mg | DRUG | 2x36mg once daily for 13 weeks |
| Placebo | DRUG | 2xplacebo once daily for 13 weeks |
Inclusion Criteria: * Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) and confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM IV * Described chronic course of ADHD symptomatology from childhood to adulthood, with some sy...
Prolonged release OROS methylphenidate is used to treat Attention Deficit/Hyperactivity Disorder (ADHD). It is an extended-release formulation studied in adults 18 years and older with ADHD. The Phase 3 trial evaluated its effectiveness and safety in this adult population.
Prolonged release OROS methylphenidate is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 3 clinical trial evaluating the drug in adults with ADHD.
Prolonged release OROS methylphenidate is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
Prolonged release OROS methylphenidate has been studied in one completed Phase 3 trial, NCT00714688, titled "A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder." The trial enrolled 279 adults across 11 European countries.