Trials / Withdrawn
WithdrawnNCT04016792
Classroom Study of SPN-812 in Children With ADHD
An Analog Classroom Study: Efficacy and Safety of SPN-812 in Children With Attention-Deficit/Hyperactivity Disorder
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Supernus Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 6 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of SPN-812, an extended-release formulation of viloxazine, compared to placebo in children in an analog classroom setting.
Detailed description
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 2-arm, analog classroom study to evaluate the efficacy and safety of 200 mg/day SPN-812 compared to placebo in the treatment of children aged 6 through 11 years with ADHD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo will be administered once daily |
| DRUG | 200 mg SPN-812 | 200 mg SPN-812 will be administered once daily and compared to Placebo |
Timeline
- Start date
- 2019-08-01
- Primary completion
- 2020-09-01
- Completion
- 2020-11-01
- First posted
- 2019-07-11
- Last updated
- 2019-09-18
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04016792. Inclusion in this directory is not an endorsement.