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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03609619 | PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations | PHASE2 | COMPLETED | 109 | — | — | Aug 17, 2018 | Nov 30, 2018 | Jul 30, 2021 | 1 | United States |
| NCT03265119 | PART A: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and With mGluR Mutations | PHASE2 | COMPLETED | 69 | — | — | Aug 28, 2017 | Oct 1, 2018 | Jul 7, 2021 | 1 | United States |
The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = "Never or rarely" to 3 = "Very often". The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value.
| Arm | Type | Description |
|---|---|---|
| AEVI-001 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AEVI-001 | DRUG | Oral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily, during the treatment period. |
| Placebo | DRUG | Oral doses of Placebo will be administered twice daily, during the treatment period. |
Inclusion Criteria: 1. Subject and parent/legally authorized representative (LAR) can speak English fluently and have provided written informed consent, and assent (as applicable) for this study. 2. Subject is 6 to 17 years of age (inclusive) at the time of consent/assent. The date of signature of ...