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Also known as KP415 oral capsule
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 |
| Axsome Therapeutics, Inc. | AXSM | 3 | PHASE3 | Solriamfetol |
KP415 is an investigational small molecule developed by Zevra Therapeutics, Inc. (ticker ZVRA) for the treatment of ADHD. It is an oral capsule that has been studied in Phase 3 clinical trials in children 6 to 12 years of age. KP415 is not yet approved and remains in clinical development.
KP415 is being developed for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children. Two completed Phase 3 trials enrolled a total of 437 participants aged 6 to 12 years in the United States. The program includes both a classroom study and an open-label safety study.
KP415 is developed by Zevra Therapeutics, Inc., which trades under the ticker ZVRA. The company is the sponsor of the KP415 clinical program in ADHD, including the Phase 3 classroom and open-label safety studies conducted in the United States.
KP415 is in Phase 3 clinical development for ADHD. Both of its Phase 3 trials have been completed, and no trials are currently active. The program has not been approved by the FDA, so KP415 remains an investigational product rather than an approved therapy.
KP415 has been studied in two completed Phase 3 trials: NCT03460652, an open-label safety study in children 6 to 12 years of age with ADHD that enrolled 282 participants, and NCT03292952, a classroom study in children 6 to 12 years of age with ADHD that enrolled 155 participants. Both were conducted in the United States.
Yes. KP415 oral capsule is another name for KP415, the investigational ADHD therapy developed by Zevra Therapeutics, Inc. (ZVRA). Both names refer to the same small molecule product candidate studied in the Phase 3 classroom and open-label safety trials in children aged 6 to 12 years.