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NCT04016779 · ClinicalTrials.gov registry record · Phase 3
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD
A Phase 3 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 374
- Enrollment target
NCT04016779: Completed Phase 3 study, sponsored by Supernus Pharmaceuticals.
NCT04016779 is a Phase 3 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 374 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04016779, a Phase 3 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 374 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of SPN-812 (Viloxazine extended-release capsules; 200-600 mg) in adults 18-65 years of age with Attention-Deficit/Hyperactivity Disorder (ADHD).
Primary Outcome
The Primary Endpoint was the change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total score at Week 6. The AISRS is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The AISRS consists of 18 items that directly correspond to the 18 symptoms of ADHD per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The scale is subdivided into two subscales: Inattention (9 items) and Hyperactivity/I
Interventions
- DRUG Placebo
- DRUG SPN-812
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2019-11-20 |
| Est. Completion | 2020-10-10 |
| Phase | Phase 3 |
What the finished NCT04016779 record still lists
NCT04016779 is an interventional study that assigns participants to a tested intervention. The registered 374 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04016779 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04016779 about?
NCT04016779 is a clinical study titled "Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD". This study will evaluate the efficacy and safety of SPN-812 (Viloxazine extended-release capsules; 200-600 mg) in adults 18-65 years of age with Attention-Deficit/Hyperactivity Disorder (ADHD).
What is the current status of trial NCT04016779?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 374 participants. The study started on 2019-11-20. Estimated completion is 2020-10-10.
What interventions are being tested in trial NCT04016779?
The interventions under investigation include: Placebo (DRUG), SPN-812 (DRUG).
Who is sponsoring clinical trial NCT04016779?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04016779's enrollment target sits among peer trials
374 991st of 2000 higher than 1,010 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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