drugset / Trial / NCT03292952
KP415 Classroom Study in Children (6-12 Years of Age) With ADHD
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The study is a multicenter, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy laboratory classroom study with KP415 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).
Timeline
- Start
- 2017-12-20
- Primary completion
- 2018-05-16
- Completion
- 2018-05-16
Outcome
Met primary endpoint
registry analysis (superiority test); Active Treatment vs Placebo Treatment; p <0.001; ANCOVA NCT03292952 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Serdexmethylphenidate | Small molecule | 28 mg | Oral |
| Subject | Serdexmethylphenidate | Small molecule | 42 mg | Oral |
| Subject | Serdexmethylphenidate | Small molecule | 56 mg | Oral |
| Subject | d-methylphenidate | Unknown | 6 mg | Oral |
| Subject | d-methylphenidate | Unknown | 9 mg | Oral |
| Subject | d-methylphenidate | Unknown | 12 mg | Oral |