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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 is a Phase 2 study that was terminated before completion, run by Supernus Pharmaceuticals. The registered enrollment target is 7 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03638466
The ClinicalTrials.gov registry entry for NCT03638466 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 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 5 interventions - of which Placebo is the first listed.
NCT03638466 reports 0 study locations.
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.
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