Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment o… (NCT02605174) | Clinical Trial Compass
CompletedPhase 3
Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine
United States3,005 participantsStarted 2016-05
Plain-language summary
This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Able and willing to give written informed consent and authorize HIPAA.
* Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004).
* History of disabling migraine for at least 1 year.
* Migraine Disability Association (MIDAS) score ≥11.
* Migraine onset before the age of 50 years.
* History of 3 - 8 migraine attacks per month (\< 15 headache days per month).
* Male or female, aged 18 years or above.
* Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
* Able and willing to complete an electronic diary to record details of the migraine attack treated with study drug.
Exclusion Criteria:
* Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
* Pregnant or breast-feeding women.
* Women of child-bearing potential not using or not willing to use highly effective contraception.
* Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
* History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.
* History of recurrent dizziness and/or vertigo including benign pa…
What they're measuring
1
Percentage of Participants Headache Pain Free at 2 Hours Post Dose
Timeframe: 2 hours post dose
2
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free