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Adult male or female, 18 to 65 years old |
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Complete at least 20 out of 28 days in the e-Diary during the screening/baseline phase |
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Negative result on the urine drug and alcohol screen at Visit 1 unless explained by permitted concomitant medication use (e.g., opioids prescribed for migraine pain |
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History of migraine headache disorder with or without aura |
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Onset of migraine before 50 years of age |
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History of 6 to 14 migraine days/month in each of the 3 months prior to Visit 1 |
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6 to 14 migraine days during the 4-week screening/baseline phase |
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<15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase |
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No current diagnosis of chronic migraine |
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No history of or current diagnosis of the following headache disorders |
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Migraine with brainstem aura or retinal migraine |
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Complications of migraine, chronic tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache |
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No history of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma) with exception that medication overuse headache is allowed |
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No history of inadequate response to >4 prophylactic treatment for migraine, 2 of which have different mechanisms of action |
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No unremitting headache lasting continuously throughout the 4-week baseline period |
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No concurrent pain condition that may significantly impact current headache disorder (e.g., fibromyalgia, craniofacial pain, TMD/TMJ) |
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Subject must not have Patient Health Questionnaire (PHQ-9) score ≥ 15 at Visit 1 |
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No significant risk of self-harm in the past 6 months prior to Visit 1 |
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No concurrent psychiatric conditions including bipolar disorder, schizophrenia, dementia, or other significant neurological disorders |
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No presence or history of any medical condition that may place the subject at increased risk following exposure to BOTOX or interfere with the study evaluation, including |
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Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function |
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Facial nerve palsy |
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Infection or dermatological condition at the site of study intervention injection |
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Any significant eyebrow or eyelid ptosis at Day 1 |
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No history of clinically significant drug or alcohol abuse within 6 months of Visit 1 |
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Must not have a condition or be in a situation which may put the participant at significant risk, may confound study results, or may interfere significantly with the participant's participation in the study |
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No known active SARS-CoV-2 infection |
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No unremitting symptoms of "Long COVID" due to prior SARS-CoV-2 infection r any other lasting symptoms that may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study |
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Participants that have received a SARS-CoV-2 vaccination must have completed their final dose of the vaccine at least 14 days prior to Day 1 (study drug administration) |
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Participant has not received any investigational product within 30 days or 5 half-lives of the drug (whichever is longer) before the first dose of the study drug and is not currently enrolled in another clinical study |
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Females of childbearing potential must have a negative serum pregnancy test at Visit 1 and 2 prior to the first dose of study drug |
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Females of childbearing potential must practice 1 protocol-specified method of birth control, that is effective from Visit 1 through at least 90 days after the last dose of study drug |
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Females must not be pregnant, breastfeeding, or considering becoming pregnant during the study or within 90 days of last dose of study drug |
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No use of opioids or barbiturates >2 days/month or any gepant in the 3 months prior to Visit 1 or during the baseline or screening phase |
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No prior use of ANY botulinum toxin (any serotype, therapeutic, or cosmetic) injections in the head, face, and/or neck in the subject's lifetime |
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No prior use of ANY botulinum toxin (any serotype, therapeutic, or cosmetic) regardless of location in the 6 months prior to Visit 1 |
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No concurrent use or use of any migraine prophylactic treatment in the 4 weeks prior to Visit 1 nor during the baseline or screening phase |
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No use of CGRP monoclonal antibody in the 6 months prior to screening |
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No concurrent use or use of acupuncture, TENS (e.g., Cefaly Dual), cranial traction, nociceptive trigeminal inhibition or occipital nerve block treatments, or injection of anesthetics or steroids into the study target muscles in the 4 weeks prior to Visit 1 |
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Participant must not have received immunization for any botulinum toxin serotype nor have a history of botulism |
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