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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02618434 | Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2) | PHASE3 | COMPLETED | 297 | — | — | Feb 16, 2016 | Feb 14, 2020 | Mar 18, 2024 | 32 | United States |
| NCT02618408 | Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1) | PHASE3 | COMPLETED | 333 | — | — | Jan 25, 2016 | Oct 24, 2019 | Jan 2, 2024 | 28 | United States |
The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the Baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 6, inclusive) and baseline period (Day ≤1), respectively. The IA behavior frequency per 7 days is defined as (SUM/DAY) x 7, where SUM is the total of the IA behaviors reported in the subject IA diary, and DAY is the number of days with a non-missing IA score in the subject IA diary during the specified study period.
| Arm | Type | Description |
|---|---|---|
| Low dose SPN-810 (18 mg) | EXPERIMENTAL | Oral |
| High dose SPN-810 (36 mg) | EXPERIMENTAL | Oral |
| Placebo | PLACEBO_COMPARATOR | Oral |
| Name | Type | Description |
|---|---|---|
| SPN-810 (18 mg) | DRUG | Subjects were randomized to receive SPN-810 9 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose. |
| SPN-810 (36 mg) | DRUG | Subjects were randomized to receive SPN-810 18 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose. |
| Placebo | DRUG | Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose. |
Inclusion Criteria: * Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized FDA-approved ADHD medication. * Impulsive aggression will be confirmed at screening using R-MO...