Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:
- Conditions
- Acute Migraine
- Interventions
- Registration Number
- NCT02439320
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2231
- Able and willing to give written informed consent.
- 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.
- 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.
- Pregnant or breast-feeding women.
- Women of child-bearing potential not using or not willing to use highly effective contraception.
- Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension.
- 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 paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
- History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
- History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
- History of orthostatic hypotension with syncope.
- Significant renal or hepatic impairment.
- Participant is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within six months prior to the screening visit.
- Known Hepatitis B or C or HIV infection.
- History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is greater than 15 headache days per month.
- Use of more than 3 doses per month of either opiates or barbiturates.
- Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lasmiditan 100 mg Lasmiditan 100 mg Oral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours. Lasmiditan 100 mg Placebo (matches lasmiditan doses) Oral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours. Lasmiditan 200 mg Placebo (matches lasmiditan doses) Oral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours. Placebo Placebo (matches lasmiditan doses) Oral tablet. Placebo tablets match lasmiditan 100 mg and lasmiditan 200 mg. One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours. Lasmiditan 200 mg Lasmiditan 200 mg Oral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Are Headache Pain Free 2 hours post dose The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Nausea Free 2 hours post dose The percentage of participants without nausea.
Percentage of Participants Photophobia Free 2 hours post dose The percentage of participants without photophobia.
Participants With Serious Adverse Events (SAE) 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
Percentage of Participants Who Have Headache Relief After First Dose 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.
Percentage of Participants Who Used Rescue Medication 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).
Percentage of Participants Phonophobia Free 2 hours post dose The percentage of participants without phonophobia.
Percentage of Participants With Headache Recurrence 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.
Trial Locations
- Locations (75)
Southview Medical Group, P.C.
🇺🇸Birmingham, Alabama, United States
Simon-Williamson Clinic
🇺🇸Birmingham, Alabama, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
East Valley Family Physicians, PC
🇺🇸Chandler, Arizona, United States
Radiant Research,Inc
🇺🇸Akron, Ohio, United States
Warner Family Practice
🇺🇸Chandler, Arizona, United States
Clinical Research Advantage/Fountain Hills Family Practice
🇺🇸Fountain Hills, Arizona, United States
Neurological Physicians of Arizona, Inc
🇺🇸Gilbert, Arizona, United States
Thunderbird Internal Medicine
🇺🇸Phoenix, Arizona, United States
Lenzmeier Family Practice
🇺🇸Glendale, Arizona, United States
Scroll for more (65 remaining)Southview Medical Group, P.C.🇺🇸Birmingham, Alabama, United States