Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine

This is an interventional prevention trial for Migraine focused on measuring Headache Read More

Inclusion Criteria:

• Males and Females, 18 to 65 years of age.
• In good general health as determined by a thorough medical history and physical examination, and vital signs.
• At least a 1-year history of migraine with or without aura that began before the age of 50 years old and consistent with a diagnosis of migraine with or without aura according to the International Classification of Headache Disorders, 3rd edition, beta version.
• Experiences 4-14 migraine days per month and 3-14 migraine attacks per month and no more than 14 headache days per month (including migraine and non-migraine headache days) in the 3 months prior to screening.
• Experiences 4-14 migraine headache days per month during the baseline period.
• Ability and willingness to abstain from taking medications not allowed by the protocol or administering any foreign substance intranasally.
• Ability and willingness to complete a migraine-history diary from screening to treatment with study drug and a migraine-treatment diary from prevention treatment through the remainder of the follow-up period.

Exclusion Criteria:

• Headache on greater than 14 days/month in any of the three months (90 days) preceding entry into the study.
• Use of acute migraine-specific medications (e.g., ergotamine, triptan) on more than 10 days per month in the previous 3 months and during study.
• Use of intranasal migraine medications during study.
• Use of any intranasally administered over-the-counter product or nasal irrigation (e.g., neti pot) during study.
• Opioids/barbiturates used on more than 4 days per month in the previous 3 months and throughout the duration of the study.
• Use of analgesics (including acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], acetylsalicylic acid, or combination analgesics) for migraine and non-migraine headaches on more than 14 days per month in the - Use of migraine prevention medication within two months prior to study and throughout the duration of the study.
• Botulinum toxin injection within 3 months prior to screening or during study.
• Anti-CGRP monoclonal antibody (e.g., erenumab, fremanezumab, galcanezumab, and eptinezumab) injection or infusion within 4 months prior to screening or during study.
• Small molecule anti-CGRP medications in the 30 days prior to the screening visit.
• Use of systemic antibiotics during study.
• Pregnancy or breast-feeding.
• Female of childbearing potential not using adequate contraceptive measures.
• Inability to give informed consent.
• History of neurological, psychiatric, or any other medical condition that in the opinion of the investigator may compromise the subject's ability to safely participate in the study.
• Subjects with any significant clinical abnormalities which may interfere with study participation.
• Prior use of AO+ Mist.
• Subjects with immunodeficiencies, nasal lesions, nasal polyps, or sinus infections.
• Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit.
• Inability to maintain at least 80% diary compliance during the study from baseline to follow-up.