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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 is a Phase 3 study that was terminated before completion, run by Supernus Pharmaceuticals. The registered enrollment target is 491 participants.
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.
Interventions
- DRUG SPN-810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 491 participants |
| Start Date | 2016-04 |
| Est. Completion | 2021-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02691182
The ClinicalTrials.gov registry entry for NCT02691182 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 491 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 1 intervention - of which SPN-810 is the first listed.
NCT02691182 reports 0 study locations.
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.
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