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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02884544 | A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD | PHASE2 | COMPLETED | 22 | — | — | Aug 1, 2016 | Dec 27, 2016 | Jul 19, 2021 | 1 | United States |
Primary outcome is the determination of the dose achieving optimal clinical effect in a safe and tolerable manner
| Arm | Type | Description |
|---|---|---|
| HLD100 10mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (10mg) |
| HLD100 20mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (20mg) |
| HLD100 30mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (30mg) |
| HLD100 40mg | EXPERIMENTAL | HLD100 (dextroamphetamine sulfate) DR/ER capsules (40mg) |
| Name | Type | Description |
|---|---|---|
| HLD100 | DRUG | Treatment |
Inclusion Criteria: * Subjects must have a diagnosis of ADHD as defined by DSM-5 criteria with confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). * Subjects must demonstrate mild-to-moderate impairment of ADHD symptoms and function per the ...