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NCT02633527 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD
A Phase 2 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 222
- Enrollment target
NCT02633527: Completed Phase 2 study, sponsored by Supernus Pharmaceuticals.
NCT02633527 is a Phase 2 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 222 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02633527, a Phase 2 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 222 participants
- Enrollment target
Study Summary
This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.
Primary Outcome
The Primary Endpoint was the change from baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) Total score at Week 8 (End of Study). The ADHD-RS-IV 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, 4th Edition (DSM-IV) symptoms of ADHD. Each item is rated on a 4-point Likert-type scale from 0 (n
Interventions
- DRUG Placebo
- DRUG 100mg SPN-812
- DRUG 400mg SPN-812
- DRUG 200mg SPN-812
- DRUG 300mg SPN-812
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2016-02-01 |
| Est. Completion | 2016-07-25 |
| Phase | Phase 2 |
What the finished NCT02633527 record still lists
NCT02633527 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02633527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02633527 about?
NCT02633527 is a clinical study titled "Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD". This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.
What is the current status of trial NCT02633527?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2016-02-01. Estimated completion is 2016-07-25.
What interventions are being tested in trial NCT02633527?
The interventions under investigation include: Placebo (DRUG), 100mg SPN-812 (DRUG), 400mg SPN-812 (DRUG), 200mg SPN-812 (DRUG), 300mg SPN-812 (DRUG).
Who is sponsoring clinical trial NCT02633527?
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 NCT02633527's enrollment target sits among peer trials
222 274th of 2000 higher than 1,726 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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