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NCT02565186 · ClinicalTrials.gov registry record · Phase 3

An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
2,171
Enrollment target

NCT02565186: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT02565186 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 2,171 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (181% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02565186, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
2,171 participants
Enrollment target

Study Summary

This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.

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

FieldValue
Enrollment Target 2,171 participants
Start Date 2015-10-07
Est. Completion 2019-08-20
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT02565186 record still lists

NCT02565186 is an interventional study that assigns participants to a tested intervention. Its 2,171 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (181% higher).

The record links to 0 conditions, and to 1 intervention - of which Lasmiditan is the first listed.

NCT02565186 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02565186 about?

NCT02565186 is a clinical study titled "An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine". This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerabi...

What is the current status of trial NCT02565186?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,171 participants. The study started on 2015-10-07. Estimated completion is 2019-08-20.

What interventions are being tested in trial NCT02565186?

The interventions under investigation include: Lasmiditan (DRUG).

Who is sponsoring clinical trial NCT02565186?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02565186's enrollment target sits among peer trials

2,171 95th of 2000 higher than 1,906 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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Source: ClinicalTrials.gov NCT02565186, the US trial registry maintained by the National Library of Medicine. NCT02565186 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.