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NCT03597503 · ClinicalTrials.gov registry record · Phase 3
Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
A Phase 3 study, sponsored by Supernus Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT03597503: Clinical Trial Phase 3 study, sponsored by Supernus Pharmaceuticals.
NCT03597503 is a Phase 3 study that was terminated before completion, run by Supernus Pharmaceuticals. The registered enrollment target is 41 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03597503, a Phase 3 study, was terminated before completion, sponsored by Supernus Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the effect of SPN-810 for the treatment of impulsive aggression (IA) in adolescents diagnosed with ADHD when taken in conjunction with standard ADHD treatment.
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 7, inclusive) and baseline period (Day ≤1), respectively. The IA behavior freq
Interventions
- DRUG Placebo
- DRUG SPN-810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-07-31 |
| Est. Completion | 2020-01-22 |
| Phase | Phase 3 |
Why NCT03597503 stopped before completion
NCT03597503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03597503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03597503 about?
NCT03597503 is a clinical study titled "Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment". The purpose of this study was to evaluate the effect of SPN-810 for the treatment of impulsive aggression (IA) in adolescents diagnosed with ADHD when taken in conjunction with standard ADHD treatment.
What is the current status of trial NCT03597503?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2018-07-31. Estimated completion is 2020-01-22.
What interventions are being tested in trial NCT03597503?
The interventions under investigation include: Placebo (DRUG), SPN-810 (DRUG).
Who is sponsoring clinical trial NCT03597503?
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 NCT03597503's enrollment target sits among peer trials
41 1877th of 2000 higher than 123 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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