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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,171
oral tablet
Number of Participants With at Least 1 Treatment Emergent Adverse Event
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.
Time frame: Up to 12 months
Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose
Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).
Time frame: Up to 12 months
Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose
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.
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Southview Medical Group
Birmingham, Alabama, United States
Simon Williamson Clinic
Birmingham, Alabama, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Medical Affiliated Research Center
Huntsville, Alabama, United States
East Valley Family Physicians, PLC
Chandler, Arizona, United States
Radiant Research
Chandler, Arizona, United States
Warner Family Practice
Chandler, Arizona, United States
Fountain Hills Family Practice, P.C.
Fountain Hills, Arizona, United States
Neurological Physicians of Arizona Inc
Gilbert, Arizona, United States
...and 186 more locations