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

Completed · Phase 2

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT03488563

Run by

AOBiome LLC

People needed

313

Starts

2018-03-30

Expected to finish

2019-07-16

Last updated by the study team

2022-10-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Collaborative Neuroscience Network, LLC — Long Beach, California, United States
• CI Trials — Riverside, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• New England Institute for Neurology and Headache (NEINH)/Medical Practice — Stamford, Connecticut, United States
• Clinical Neuroscience Solution, Inc — Jacksonville, Florida, United States
• Precision Clinical Research — Lauderdale Lakes, Florida, United States
• Clinical Neuroscience Solution, Inc — Orlando, Florida, United States
• Palm Beach Research — West Palm Beach, Florida, United States
• Neurostudies Clinical Research — Decatur, Georgia, United States
• BTC of New Bedford — New Bedford, Massachusetts, United States
• MedVadis Research — Watertown, Massachusetts, United States
• Altea Research Institute — Las Vegas, Nevada, United States
• Rochester Clinical Research INC — Rochester, New York, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• Coastal Carolina Research Center — North Charleston, South Carolina, United States
• Clinical Neuroscience Solution, Inc — Memphis, Tennessee, United States
• FutureSearch Trials of Neurology and Sleep Lab, L.P. — Austin, Texas, United States
• FutureSearch Trials of Dallas, L.P. — Dallas, Texas, United States
• Texas Center for Drug Development — Houston, Texas, United States
• Charlottesville Medical Research — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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