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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01107496 | Evaluation of Immediate-Release Viloxazine in Adults With ADHD | PHASE1 | COMPLETED | 52 | — | — | Jun 1, 2010 | Dec 1, 2010 | Oct 15, 2024 | 4 | United States |
The percent of subjects who took at least one dose of immediate-release viloxazine (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 |
|---|---|---|
| IR Viloxazine | EXPERIMENTAL | Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day |
| Placebo | PLACEBO_COMPARATOR | Treatment B: Placebo capsules administered orally 3 times a day |
| Name | Type | Description |
|---|---|---|
| IR Viloxazine | DRUG | One 50mg immediate-release viloxazine capsule administered orally 3 times a day (150mg total daily dose) for Week 1. Two 50mg immediate-release viloxazine capsules administered orally 3 times a day (300mg total daily dose) for Weeks 2 to 6. |
| Placebo | DRUG | Placebo capsules administered orally 3 times a day |
Inclusion criteria: 1. Able to provide informed consent prior to any study procedure being conducted. 2. Capable and willing to comply with study procedures. 3. Male or female aged 18 to 64, inclusive. 4. Subjects with a current diagnosis of ADHD as confirmed by the Conners' Adult ADHD Diagnostic I...