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NCT03247556 · ClinicalTrials.gov registry record · Phase 3
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD
A Phase 3 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 297
- Enrollment target
NCT03247556: Completed Phase 3 study, sponsored by Supernus Pharmaceuticals.
NCT03247556 is a Phase 3 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 297 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03247556, a Phase 3 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 297 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents (12-17 years old) with ADHD
Primary Outcome
The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 7 (End of Study). The ADHD-RS-5 is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology. The scale consists of 18 items that directly correspond to the 18 Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (
Interventions
- DRUG Placebo
- DRUG 400mg SPN-812
- DRUG 600mg SPN-812
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2017-11-20 |
| Est. Completion | 2019-02-14 |
| Phase | Phase 3 |
What the finished NCT03247556 record still lists
NCT03247556 is an interventional study that assigns participants to a tested intervention. The registered 297 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 (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03247556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03247556 about?
NCT03247556 is a clinical study titled "Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD". This study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents (12-17 years old) with ADHD
What is the current status of trial NCT03247556?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 297 participants. The study started on 2017-11-20. Estimated completion is 2019-02-14.
What interventions are being tested in trial NCT03247556?
The interventions under investigation include: Placebo (DRUG), 400mg SPN-812 (DRUG), 600mg SPN-812 (DRUG).
Who is sponsoring clinical trial NCT03247556?
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 NCT03247556's enrollment target sits among peer trials
297 1163rd of 2000 higher than 837 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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