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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03460652 | KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD | PHASE3 | COMPLETED | 282 | — | — | Mar 13, 2018 | Jul 9, 2019 | Jul 19, 2021 | 19 | United States |
| NCT03292952 | KP415 Classroom Study in Children (6-12 Years of Age) With ADHD | PHASE3 | COMPLETED | 155 | — | — | Dec 20, 2017 | May 16, 2018 | Jun 30, 2021 | 5 | United States |
TEAEs will be assessed starting following the first dose of study drug, and ending with the Follow-Up Visit or Early Termination Visit.
The SKAMP scale is a validated rating of subjective impairment of classroom behaviors in children with ADHD. It comprises 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment) by trained study personnel (Swanson 1998). The SKAMP-C score was obtained by summing the rating values for each of the 13 items (range: 0-78), with higher scores indicating greater impairment.
| Arm | Type | Description |
|---|---|---|
| Open-Label KP415 | EXPERIMENTAL | KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule: 28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl) |
| Double-blind KP415 | EXPERIMENTAL | KP415 (serdexmethylphenidate \[SDX\] Cl/ d-methylphenidate \[d-MPH\] HCl) oral capsule: 28/6 mg SDX/d-MPH (molar equivalent to 20 mg d-MPH HCl), 42/9 mg SDX/d-MPH (molar equivalent to 30 mg d-MPH HCl), 56/12 mg SDX/d-MPH (molar equivalent to 40 mg d-MPH HCl) |
| Double-blind Placebo | PLACEBO_COMPARATOR | Placebo oral capsule |
| Name | Type | Description |
|---|---|---|
| KP415 oral capsule | DRUG | Once-daily oral dose |
| Placebo oral capsule | DRUG | Daily dose |
Inclusion Criteria: 1. Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive presentation) per clinical evaluation and confirmed by the Mini International Neuropsychia...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |