Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks - H8H-MC-LAIJ

Eli Lilly0 个研究点目标入组 37 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•- Are of an acceptable age to provide informed consent according to the local regulations and are at least 18 years of age at time of screening (Visit 1) with migraine with or without aura fulfilling the IHS (International Headache Society) diagnostic criteria 1.1 or 1.2.1.
•- History of disabling migraine for at least 1 year.
•- Migraine onset before the age of 50 years.
•- History of 3 to 8 migraine attacks per month (< 15 headache days per month).
•- MIDAS score >=11.
•- Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug.
•- women of child-bearing potential must agree to use a highly effective method of contraception (that is, one with less than 1% failure rate) such as combination oral contraceptives, implanted/ injected contraceptives, intrauterine devices, or sterile partner until 30 days after the last dose of study medication.
•- Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed.
•- Are able and willing to give signed informed consent

•-Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
•- increased risk of seizures
•-History of recurrent dizziness and/or vertigo
•-History of diabetes mellitus with complications
•-History of orthostatic hypotension with syncope
•-Significant renal or hepatic impairment
•-Patients who, in the investigator*s judgment, are actively suicidal
•-History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is >=15 headache days per month
•- Use of more than 3 doses per month of either opioids or barbiturates
•- Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to Screening/Visit 1
•-Pregnant or breast-feeding women
•- History of drug or alcohol abuse/dependence within 1 year prior to Visit 1
•- have an acute, serious or unstable medical condition, or a history or presence of
•any other medical illness
•-Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
•-Currently enrolled in any other clinical study involving an investigational product
•-Relatives of, or staff directly reporting to, the Investigator.
•-Participants who are employees of the sponsor.

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