Status:
COMPLETED
A Study of Lasmiditan in Participants With Migraine
Lead Sponsor:
Eli Lilly and Company
Conditions:
Migraine Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it during an acute migraine attack and also during the time between...
Eligibility Criteria
Inclusion
- Males or females with history of migraine with or without aura, as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 and 1.2) (ICHD-3 beta, Cephalalgia 2013), for at least 1 year, based on medical history
- Have a body mass index (BMI) of 18.0 to 40.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening
Exclusion
- Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan
- Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
- Have an abnormal blood pressure, defined as systolic blood pressure less than or equal to (≤) 90 or greater than (\>) 155 millimeters of mercury (mmHg) or diastolic blood pressure ≤ to 50 or \>95 mmHg
- Have clinically significant electrocardiogram (ECG) findings, including a QT interval corrected for heart rate using QT interval corrected for heart rate using Fridericia's formula (QTcF) value \>450 milliseconds (ms) (males) or \>470 ms (females), clinically significant bradycardia, cardiac block, or bradyarrhythmias
- Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, major depressive disorder)
- Have a history of gastrointestinal surgery, or a history of or current irritable bowel syndrome, mal-absorptive disorders, or other gastrointestinal motility disorders. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
- Have used or intend to use any migraine prevention treatments (including, but not limited to, propranolol or topiramate) within 30 days prior to dosing and until the follow-up visit
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03247790
Start Date
August 16 2017
End Date
January 15 2018
Last Update
December 2 2019
Active Locations (3)
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1
eStudySite
San Diego, California, United States, 92120
2
AGA Clinical Trials
Hialeah, Florida, United States, 33012
3
Meridien Research Inc.
Tampa, Florida, United States, 33634