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NCT04050293 · ClinicalTrials.gov registry record · Phase 4
Therapy for Migraine Prevention in Children 6-11 Years of Age
A Phase 4 study, sponsored by Supernus Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT04050293: Clinical Trial Phase 4 study, sponsored by Supernus Pharmaceuticals.
NCT04050293 is a Phase 4 study that was terminated before completion, run by Supernus Pharmaceuticals. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04050293, a Phase 4 study, was terminated before completion, sponsored by Supernus Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate the effect of SPN-538 for the prophylaxis of migraine in pediatric patients 6 to 11 years old.
Primary Outcome
The primary efficacy endpoint was the change in rate of the MMDs relative to the Prospective Baseline Period (PBP). The 28-day rate of MMDs was calculated as the ratio of the # days of migraine during the last 4 weeks of PBP and the # days with non-missing headache record in the electronic diary during the last 4 weeks of the 20-week double-blind Treatment Phase, x 28. The primary outcome measure was recorded on headache electronic diary uploaded on a Patient Reported Outcome (ePRO) application.
Interventions
- DRUG Placebo
- DRUG SPN-538
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-07-14 |
| Est. Completion | 2023-03-01 |
| Phase | Phase 4 |
Why NCT04050293 stopped before completion
NCT04050293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 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.
NCT04050293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04050293 about?
NCT04050293 is a clinical study titled "Therapy for Migraine Prevention in Children 6-11 Years of Age". The aim of this study is to evaluate the effect of SPN-538 for the prophylaxis of migraine in pediatric patients 6 to 11 years old.
What is the current status of trial NCT04050293?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2020-07-14. Estimated completion is 2023-03-01.
What interventions are being tested in trial NCT04050293?
The interventions under investigation include: Placebo (DRUG), SPN-538 (DRUG).
Who is sponsoring clinical trial NCT04050293?
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 NCT04050293's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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