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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04143217 | Open-label Long-Term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD | PHASE3 | COMPLETED | 159 | — | — | Jan 23, 2020 | Dec 14, 2022 | Feb 13, 2024 | 38 | United States |
| NCT02736656 | Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) | PHASE3 | ACTIVE NOT_RECRUITING | 1,400 | — | — | Feb 2, 2016 | Sep 1, 2026 | Jun 25, 2025 | 16 | United States |
The percent of subjects who took at least one dose of SPN-812 (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population
| Arm | Type | Description |
|---|---|---|
| Open-Label Treatment | EXPERIMENTAL | SPN-812 Open-Label Treatment 200mg to 600mg SPN-812 once daily for up to 156 weeks |
| Name | Type | Description |
|---|---|---|
| SPN-812 | DRUG | SPN-812 200 to 600 mg/day |
\*Please note, Inclusion/Exclusion Criterion "A" applies to subjects who completed Study 812P306 and enrolled in Study 812P311 on either the same day or up to 7 days after the end of Study 812P306. Inclusion/Exclusion Criterion "B" applies to subjects who completed Study 812P306, but enrolled in stu...