drugset / Trial / NCT02633527
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.
Timeline
- Start
- 2016-02-01
- Primary completion
- 2016-07-25
- Completion
- 2016-07-25
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs 200mg SPN-812; p = 0.0310; Mean Difference (Final Values) -7.9 (95% CI -15.1 to -0.7); ANOVA NCT02633527 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Viloxazine | Small molecule | 100 mg | Oral |
| Subject | Viloxazine | Small molecule | 200 mg | Oral |
| Subject | Viloxazine | Small molecule | 300 mg | Oral |
| Subject | Viloxazine | Small molecule | 400 mg | Oral |