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NCT03638466 · ClinicalTrials.gov registry record · Phase 2
Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD
A Phase 2 study, sponsored by Supernus Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03638466: Clinical Trial Phase 2 study, sponsored by Supernus Pharmaceuticals.
NCT03638466 is a Phase 2 study that was terminated before completion, run by Supernus Pharmaceuticals. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03638466, a Phase 2 study, was terminated before completion, sponsored by Supernus Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the effect of 4-week SPN-810 treatment on brain functioning in patients aged 8-12 years with ADHD and associated feature of impulsive aggression (IA). This was achieved using functional magnetic resonance imaging (fMRI) in conjunction with the point subtraction aggression paradigm (PSAP) Task, a behavioral aggression paradigm in which subjects are provoked by having money indirectly taken from them by a fictitious opponent, simulating an aggression response.
Primary Outcome
The primary endpoint was the aggression-related change in the whole brain in BOLD signal fMRI contrast in response to the PSAP task. BOLD fMRI contrast (neural activation) investigates brain activity by measuring the change in blood oxygenation. Change in brain activity was measured by a change in BOLD response in brain regions during the aggressive response relative to the monetary response, where the aggression was defined as the number of Option 2 presses (aggressive response) divided by the
Interventions
- DRUG Placebo
- DIAGNOSTIC_TEST Functional Magnetic Resonance Imaging (fMRI)
- DRUG SPN-810
- DIAGNOSTIC_TEST Magnetic Resonance Spectroscopy (MRS)
- BEHAVIORAL Point Subtraction Aggression Paradigm (PSAP) Task
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-05-30 |
| Est. Completion | 2019-11-07 |
| Phase | Phase 2 |
Why NCT03638466 stopped before completion
NCT03638466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03638466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03638466 about?
NCT03638466 is a clinical study titled "Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD". The purpose of this study was to evaluate the effect of 4-week SPN-810 treatment on brain functioning in patients aged 8-12 years with ADHD and associated feature of impulsive aggression (IA). This was achieved using functional magnetic resonance imaging (fMRI) in conjunction with the point subtract...
What is the current status of trial NCT03638466?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2019-05-30. Estimated completion is 2019-11-07.
What interventions are being tested in trial NCT03638466?
The interventions under investigation include: Placebo (DRUG), Functional Magnetic Resonance Imaging (fMRI) (DIAGNOSTIC_TEST), SPN-810 (DRUG), Magnetic Resonance Spectroscopy (MRS) (DIAGNOSTIC_TEST), Point Subtraction Aggression Paradigm (PSAP) Task (BEHAVIORAL).
Who is sponsoring clinical trial NCT03638466?
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 NCT03638466's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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