CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,171 enrolled
Drug / intervention
Lasmiditandrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02565186
NCT02565186Phase 3Completed
CompareCT.gov

An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)

Eli Lilly and Company·interventional·Posted Oct 1, 2015·Updated Aug 25, 2020

In Brief

A Phase 3 clinical trial evaluating Lasmiditan for Migraine Disorders. Completed, enrolled 2,171 participants across 196 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Disorders
CountriesGermany, United Kingdom, United States
CollaboratorsCoLucid Pharmaceuticals

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 1, 2015
Enrollment StartOct 7, 2015
Primary CompletionAug 20, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.8 years ago

Interventions

Lasmiditandrug

oral tablet