An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine (GLADIATOR)
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|ClinicalTrials.gov Identifier: NCT02565186|
Recruitment Status : Completed
First Posted : October 1, 2015
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorders||Drug: Lasmiditan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2171 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)|
|Actual Study Start Date :||October 7, 2015|
|Actual Primary Completion Date :||August 20, 2019|
|Actual Study Completion Date :||August 20, 2019|
Experimental: Lasmiditan 100mg
Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Other Name: LY573144
Experimental: Lasmiditan 200mg
Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Other Name: LY573144
- Number of Participants With at Least 1 Treatment Emergent Adverse Event [ Time Frame: Up to 12 months ]
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.
- Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose [ Time Frame: Up to 12 months ]Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).
- Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose [ Time Frame: Up to 12 months ]MBS-free, defined as the absence of the associated symptom of migraine (nausea, phonophobia, and/or photophobia) at 2 hours postdose that was identified predose as the most bothersome symptom.
- Percentage of Participants With Medical Resource Utilization [ Time Frame: Up to 12 months ]Medical Resource utilization for any cardiovascular (CV) events and/or related resource utilization, such as visits to cardiologists, procedures, hospitalizations, new treatments or treatment adjustments for CV disease and any visits to an emergency room (ER) or physician's office for treatment of migraine was reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565186
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|