Brief Summary
This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).
Brief Title
Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Migraine
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
Inclusion Criteria
Inclusion Criteria:
* 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02439320
Org Class
Industry
Org Full Name
Eli Lilly and Company
Org Study Id
16888
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Outcome Measure
Percentage of Participants Who Are Headache Pain Free
Outcome Time Frame
2 hours post dose
Outcome Description
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
Outcome Measure
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
Outcome Time Frame
2 hours post dose
Secondary Ids
Secondary Id
H8H-CD-LAHJ
Secondary Id
COL MIG-301
Secondary Outcomes
Outcome Description
The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
Outcome Time Frame
2 hours post dose
Outcome Measure
Percentage of Participants Who Have Headache Relief After First Dose
Outcome Description
Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.
Outcome Time Frame
From 2 hours post dose up to 48 hours
Outcome Measure
Percentage of Participants With Headache Recurrence
Outcome Description
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Outcome Time Frame
2 hours post dose
Outcome Measure
Percentage of Participants Who Used Rescue Medication
Outcome Description
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Outcome Time Frame
Anytime between 2-24 hours post dose
Outcome Measure
Percentage of Participants Who Used Rescue Medication
Outcome Description
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Outcome Time Frame
Anytime 24-48 hours post dose
Outcome Measure
Percentage of Participants Who Used Rescue Medication
Outcome Description
The percentage of participants without nausea.
Outcome Time Frame
2 hours post dose
Outcome Measure
Percentage of Participants Nausea Free
Outcome Description
The percentage of participants without phonophobia.
Outcome Time Frame
2 hours post dose
Outcome Measure
Percentage of Participants Phonophobia Free
Outcome Description
The percentage of participants without photophobia.
Outcome Time Frame
2 hours post dose
Outcome Measure
Percentage of Participants Photophobia Free
Outcome Description
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
Outcome Time Frame
Baseline up to 11 weeks
Outcome Measure
Participants With Serious Adverse Events (SAE)
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sarah Vollbracht
Investigator Email
SAVOLLBR@montefiore.org
Investigator Phone