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NCT02618434 · ClinicalTrials.gov registry record · Phase 3
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
A Phase 3 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 297
- Enrollment target
NCT02618434: Completed Phase 3 study, sponsored by Supernus Pharmaceuticals.
NCT02618434 is a Phase 3 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 297 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02618434, a Phase 3 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 297 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 297 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression and quality of life measures for the subject and caregiver will be assessed using validated scales.
Primary Outcome
The primary efficacy endpoint was percent change (PCHT) in the frequency (unweighted score) of IA behaviors per 7 days in the treatment (titration and maintenance) period relative to the Baseline period calculated over the number of days with non-missing IA diary data. PCHT was then calculated as 100 x (T - B)/B, where T and B are IA behavior frequencies per 7 days during the treatment period (from Day 2 through Visit 6, inclusive) and baseline period (Day ≤1), respectively. The IA behavior freq
Interventions
- DRUG Placebo
- DRUG SPN-810 (18 mg)
- DRUG SPN-810 (36 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2016-02-16 |
| Est. Completion | 2020-02-14 |
| Phase | Phase 3 |
What the finished NCT02618434 record still lists
NCT02618434 is an interventional study that assigns participants to a tested intervention. The registered 297 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 (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02618434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02618434 about?
NCT02618434 is a clinical study titled "Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)". The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of impulsive aggression in patients with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 297 subjects aged 6 to 12 years with ADHD...
What is the current status of trial NCT02618434?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 297 participants. The study started on 2016-02-16. Estimated completion is 2020-02-14.
What interventions are being tested in trial NCT02618434?
The interventions under investigation include: Placebo (DRUG), SPN-810 (18 mg) (DRUG), SPN-810 (36 mg) (DRUG).
Who is sponsoring clinical trial NCT02618434?
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 NCT02618434's enrollment target sits among peer trials
297 1163rd of 2000 higher than 837 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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