Approval Probability
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Adjusted LOA
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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 for Attention Deficit/Hyperactivity Disorder (ADHD). It is an investigational small molecule being studied in adults with ADHD. The drug is in Phase 3 clinical development and has not been approved by regulatory authorities.
Prolonged release 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 adults with Attention Deficit/Hyperactivity Disorder.
Prolonged release OROS methylphenidate is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved for marketing. The Phase 3 trial has been completed, and the drug remains under clinical investigation for ADHD.
Prolonged release OROS methylphenidate has one completed Phase 3 trial, NCT00714688, which evaluated its effectiveness and safety in adults with Attention Deficit/Hyperactivity Disorder. The randomized, double-blind, placebo-controlled study enrolled 279 participants across multiple European countries.
Prolonged release OROS methylphenidate is a specific formulation of methylphenidate that uses an osmotic release oral system (OROS) to provide prolonged drug release. It is being studied for ADHD in adults and is distinct from immediate-release methylphenidate formulations.