Table 1.
Summary of Phase 3 Clinical Trials Evaluating SPN-812 in Children and Adolescents
| Age group |
Children (6–11 years) |
Adolescents (12–17 years) |
||
|---|---|---|---|---|
| Study number | P301 | P303 | P302 | P304 |
| N randomized/ITT population | 477/460 | 310/301 | 313/301 | 297/292 |
| Treatment Na SPN-812/placebo |
305/155 | 204/97 | 197/94 | 196/96 |
| SPN-812 doses (per day) | 100 mg, 200 mg | 200 mg, 400 mg | 200 mg, 400 mg | 400 mg, 600 mg |
| Weeks (t + m) | 6 (1 + 5) | 8 (≤3 + 5) | 6 (1 + 5) | 7 (2 + 5) |
| End of study assessment | Week 6 (day 42) | Week 8 (day 56) | Week 6 (day 42) | Week 7 (day 49) |
a
Based on the ITT population.
ITT, intent-to-treat; m, maintenance dosing; t, titration dosing.