Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00714688 | A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder | PHASE3 | COMPLETED | 279 | — | — | Feb 1, 2008 | Apr 1, 2009 | May 8, 2014 | 42 | Belgium, Denmark +9 |
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...