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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 is a Phase 2 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 121 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01364662
The ClinicalTrials.gov registry entry for NCT01364662 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Supernus Pharmaceuticals, which has 57 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01364662 reports 0 study locations.
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.
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