Lasmiditan 100 mg
DrugOther names: LY573144
NCT Number: NCT02439320
This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Achieve Clinical Research, LLC, Birmingham, Alabama, United States
Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of a screening visit (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS) visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately 11 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: LY573144
Other names: LY573144
Time frame: 2 hours post dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Time frame: 2 hours post dose
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
Time frame: 2 hours post dose
The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
Time frame: From 2 hours post dose up to 48 hours
Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.
Time frame: 2 hours post dose
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Time frame: Anytime between 2-24 hours post dose
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Time frame: Anytime 24-48 hours post dose
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Time frame: 2 hours post dose
The percentage of participants without nausea.
Time frame: 2 hours post dose
The percentage of participants without phonophobia.
Time frame: 2 hours post dose
The percentage of participants without photophobia.
Time frame: Baseline up to 11 weeks
Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section
Time frame: 6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack
Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study
Eli Lilly and Company
Industry
A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study
Acronym: SAMURAI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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