Health Condition 1: G431- Migraine with aura
Conditions
Interventions
Intervention1: Lasmiditan: The efficacy of lasmiditan 100 mg and 200 mg will be assessed during the first attack by comparing with the results with placebo in the control group.
The number of attacks
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: [1] 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 diagnostic criteria 1.1 or 1.2.1 [2] history of disabling migraine for at least 1 year [3] migraine onset before the age of 50 years [4] history of 3 to 8 migraine attacks per month ( past 3 months [5] MIDAS score �11 [6] able and willing to complete an eDiary to record the details of each migraine attack treated with study drug [7] are men or women; if women, must agree to abide by the following guidance: 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
Exclusion criteria
Exclusion criteria: [1] known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets [2] history or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures [3] history of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniereââ?¬•s disease, vestibular migraine, and other vestibular disorders [4] history of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy) [5] history of orthostatic hypotension with syncope [6] significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria [7] 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 ââ?°Â¥15 headache days per month [8] use of more than 3 doses per month of either opioids or barbiturates [9] initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to Screening/Visit 1 [10] female patients who are pregnant or breast-feeding [11] women of child-bearing potential who test positive for pregnancy based on a serum pregnancy test collected at Visit 1 [12] history of drug or alcohol abuse/dependence within 1 year prior to Visit 1(excessive or compulsive use as judged by the investigator), or currently using drugs of potential abuse or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse/dependence [13] have a positive urine drug screen for any substances of abuse at Visit 1 [14] have an acute, serious or unstable medical condition, or a history or presence of any other medical illness including but not limited to any autoimmune disease,CV, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, or any clinically significant laboratory abnormality, that, in the judgment of the investigator, indicates a medical problem that would preclude study participation [15] known hypersensitivity to multiple drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of lasmiditan 200 mg and 100 mg on migraine headache pain freedom compared to placebo.Timepoint: The proportion of patients in each group that are pain-free at 2 hours postdose during the first attack. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of lasmiditan 200 mg and 100 mg at 2 hours on freedom from symptoms associated with migraine compared to placeboTimepoint: The proportion of patients in each group that are free of symptoms associated with migraine at 2 hours postdose during the first attack, including each of the following: phonophobia, photophobia, nausea, and vomiting;To evaluate the efficacy of lasmiditan 200 mg and 100 mg on freedom from MBS compared to placeboTimepoint: The proportion of patients in each group that are free of MBS associated with migraine at 2 hours postdose during the first attack;To evaluate the efficacy of lasmiditan 200 mg and 100 mg on pain relief compared to placeboTimepoint: The proportion of patients with pain relief (defined as moderate or severe headache pain becoming mild or none and mild pain becoming none) in each group at 2 hours post dose during the first attack.;To evaluate the efficacy of lasmiditan 200 mg and 100 mg on sustained freedom from pain compared to placeboTimepoint: The proportion of patients in each group with 24-hour and with 48-hour sustained pain freedom during the first attack defined as pain-free at 2 and 24 hours, and 2 and 48 hours, respectively, with no rescue medication;To evaluate the need for rescue medication in patients treated with lasmiditan 200 mg and 100 mg compared to placeboTimepoint: The proportion of patients in each group requiring rescue medication for migraine within 24 hours of treatment during the first attack | — |
Countries
Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Hungary, India, Italy, Mexico, Netherlands, Russian Federation, Spain, Switzerland, United Kingdom, United States of America
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company(India) Pvt Ltd
Outcome results
None listed