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NCT02691182 · ClinicalTrials.gov registry record · Phase 3
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)
A Phase 3 study, sponsored by Supernus Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 491
- Enrollment target
NCT02691182: Clinical Trial Phase 3 study, sponsored by Supernus Pharmaceuticals.
NCT02691182 is a Phase 3 study that was terminated before completion, run by Supernus Pharmaceuticals. The registered enrollment target is 491 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02691182, a Phase 3 study, was terminated before completion, sponsored by Supernus Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 491 participants
- Enrollment target
Study Summary
Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study were invited to participate in this study. This was a Phase 3 open-label extension (OLE) study to collect long-term safety data on the use of SPN-810 in treating impulsive aggression in pediatric subjects with ADHD when taken in conjunction with standard ADHD treatment. After confirmation of eligibility, all subjects were treated with SPN-810. Subjects were given a choice to extend participation in this study every 6 months for up to 36 months.
Primary Outcome
R-MOAS scale gauges the severity of aggressive behavior: the frequency of the 16 behaviors is rated over the past week in 4 areas (VE, PH, PR, SE). For each open question in each area, the parent-rated the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: Verbal Incidents (VE)=1, Incidents Toward Other (PH) =4, Incidents Involving Property (PR)=2 and Incidents Directed Toward Self (SE)=3. Therefore, the sum of each area yields a maximum weig
Interventions
- DRUG SPN-810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 491 participants |
| Start Date | 2016-04 |
| Est. Completion | 2021-05 |
| Phase | Phase 3 |
Why NCT02691182 stopped before completion
NCT02691182 is an interventional study that assigns participants to a tested intervention. The registered 491 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 1 intervention - of which SPN-810 is the first listed.
NCT02691182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02691182 about?
NCT02691182 is a clinical study titled "Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)". Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study were invited to participate in this study. This was a Phase 3 open-label extension (OLE) study to collect long-term safety data on the use of S...
What is the current status of trial NCT02691182?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 491 participants. The study started on 2016-04. Estimated completion is 2021-05.
What interventions are being tested in trial NCT02691182?
The interventions under investigation include: SPN-810 (DRUG).
Who is sponsoring clinical trial NCT02691182?
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 NCT02691182's enrollment target sits among peer trials
491 781st of 2000 higher than 1,219 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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