Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KP415 · 2 trials · 1 indication
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 |
KP415 is an investigational small molecule being developed for the treatment of attention deficit hyperactivity disorder (ADHD). It is currently in Phase 3 clinical development and has not been approved by the FDA. Two Phase 3 trials have been completed in children aged 6 to 12 years with ADHD.
KP415 is being developed by Zevra Therapeutics, Inc., a company traded on the NASDAQ under the ticker symbol ZVRA. The drug is an investigational small molecule intended for the treatment of ADHD and is currently in Phase 3 clinical development.
KP415 is in Phase 3 clinical development for the treatment of ADHD. It is an investigational drug and has not been approved by the FDA. Two Phase 3 trials have been completed, both involving children aged 6 to 12 years with ADHD.
KP415 has completed two Phase 3 clinical trials. NCT03292952 was a classroom study in children aged 6 to 12 years with ADHD, enrolling 155 participants. NCT03460652 was an open-label safety study in the same population, enrolling 282 participants. Both trials were conducted in the United States.
KP415 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of ADHD. Two Phase 3 trials have been completed, but the drug has not received regulatory approval.