Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: B244; Vehicle
Intervention description: B244 Suspension; Vehicle Suspension
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization will be 1:1:1 so that equal number of subjects will be treated in each arm of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Each participant scheduled to receive investigational product (IP) will receive a randomization number at the time of randomization. The randomization number will be used to identify the study medication kit assigned to the participant and indicate the treatment to be administered to that participant.
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Headache

Summary:

      This is a prospective, randomized, vehicle-controlled, double-blind, multi-center study
      assessing the safety, tolerability, and efficacy of B244 delivered as an intranasal spray for
      preventive treatment in subjects with episodic migraine.
    

Eligibility criteria:

        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.