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NCT04396574 · ClinicalTrials.gov registry record · Phase 3
A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
A Phase 3 study, sponsored by Eli Lilly and Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 558
- Enrollment target
NCT04396574: Clinical Trial Phase 3 study, sponsored by Eli Lilly and Company.
NCT04396574 is a Phase 3 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 558 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04396574, a Phase 3 study, was terminated before completion, sponsored by Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 558 participants
- Enrollment target
Study Summary
The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.
Primary Outcome
An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Interventions
- DRUG Lasmiditan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2025-12-04 |
| Phase | Phase 3 |
Why NCT04396574 stopped before completion
NCT04396574 is an interventional study that assigns participants to a tested intervention. The registered 558 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 (28% lower).
The record links to 0 conditions, and to 1 intervention - of which Lasmiditan is the first listed.
NCT04396574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04396574 about?
NCT04396574 is a clinical study titled "A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine". The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.
What is the current status of trial NCT04396574?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2020-06-30. Estimated completion is 2025-12-04.
What interventions are being tested in trial NCT04396574?
The interventions under investigation include: Lasmiditan (DRUG).
Who is sponsoring clinical trial NCT04396574?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04396574's enrollment target sits among peer trials
558 673rd of 2000 higher than 1,327 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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