This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,231
Percentage of Participants Who Are Headache Pain Free
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Time frame: 2 hours post dose
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
Time frame: 2 hours post dose
Percentage of Participants Who Have Headache Relief After First Dose
The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
Time frame: 2 hours post dose
Percentage of Participants With Headache Recurrence
Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.
Time frame: From 2 hours post dose up to 48 hours
Percentage of Participants Who Used Rescue Medication
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Time frame: 2 hours post dose
Percentage of Participants Who Used Rescue Medication
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Time frame: Anytime between 2-24 hours post dose
Percentage of Participants Who Used Rescue Medication
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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
Chandler, Arizona, 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
Glendale, Arizona, United States
Lenzmeier Family Practice
Glendale, Arizona, United States
...and 82 more locations
Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Time frame: Anytime 24-48 hours post dose
Percentage of Participants Nausea Free
The percentage of participants without nausea.
Time frame: 2 hours post dose
Percentage of Participants Phonophobia Free
The percentage of participants without phonophobia.
Time frame: 2 hours post dose
Percentage of Participants Photophobia Free
The percentage of participants without photophobia.
Time frame: 2 hours post dose
Participants With Serious Adverse Events (SAE)
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
Time frame: Baseline up to 11 weeks