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NCT01364662 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
NCT01364662: Completed Phase 2 study, sponsored by Supernus Pharmaceuticals.
NCT01364662 is a Phase 2 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 121 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01364662, a Phase 2 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
Study Summary
This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.
Interventions
- DRUG Placebo
- DRUG SPN-810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT01364662 record still lists
NCT01364662 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01364662 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01364662 about?
NCT01364662 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)". This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a dia...
What is the current status of trial NCT01364662?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2011-06. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01364662?
The interventions under investigation include: Placebo (DRUG), SPN-810 (DRUG).
Who is sponsoring clinical trial NCT01364662?
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 NCT01364662's enrollment target sits among peer trials
121 567th of 2000 higher than 1,432 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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