Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03488563 |
Recruitment Status :
Completed
First Posted : April 5, 2018
Last Update Posted : July 30, 2020
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Condition or disease | Intervention/treatment | Phase |
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Migraine | Biological: B244 Biological: Vehicle | Phase 2 |
This is a Prospective, Randomized, Vehicle-controlled, Double-blind, Multi-center, 3-arm study assessing the safety, tolerability, and efficacy of B244 delivered as an intranasal spray for preventive treatment in subjects with episodic migraine.
At Screening and Baseline, all subjects must experiences 4-14 migraine days per month and 3-14 migraine attacks per month and no more than 14 headache days per month in the 3 months prior to screening.
The total duration of the study will be approximately 16 weeks. Participants will report for a Screening visit and if all inclusion criteria are met, subjects will go through a one month baseline period prior to randomization. Subjects will come in for visits at Day 28 (Week 4), Day 56 (Week8), Day 84 (Week12), and Day 112 (Week 16).
Efficacy will be assessed by change in migraine attacks, days, and hours. Blood and urine samples will be collected for standard safety laboratory testing and the effect of the drug on inflammatory biomarkers. Safety will be monitored throughout the study.
Investigators plan to enroll 303 total subjects. Subjects will be randomized 1:1:1 so that an equal number of subjects will be treated in each arm of the study.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 313 participants |
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. |
Primary Purpose: | Prevention |
Official Title: | A Prospective, Randomized, Vehicle-Controlled, Double-Blind, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of B244 Delivered as an Intranasal Spray for Preventive Treatment in Subjects With Episodic Migraine |
Actual Study Start Date : | March 30, 2018 |
Actual Primary Completion Date : | June 17, 2019 |
Actual Study Completion Date : | July 16, 2019 |

Arm | Intervention/treatment |
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Experimental: B244 Dose 1
B244 1X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
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Biological: B244
B244 Suspension |
Experimental: B244 Dose 2
B244 4X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
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Biological: B244
B244 Suspension |
Placebo Comparator: Vehicle
Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
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Biological: Vehicle
Vehicle Suspension |
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Baseline to Day 112 ]Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
- Mean change in monthly migraine days. [ Time Frame: Baseline to Day 84 ]
- Mean change in monthly migraine attacks. [ Time Frame: Baseline to Day 84 ]
- Proportion of subjects experiencing a 50%, 75%, and 100% reduction in monthly migraine days. [ Time Frame: Baseline to Day 112 ]
- Mean change in monthly acute migraine specific medication days. [ Time Frame: Baseline to Day 84 ]
- Mean change from baseline to 12 weeks of treatment in disability, as measured by the Migraine Disability Assessment (MIDAS) [ Time Frame: Baseline to Day 84 ]
- Mean change from baseline to 12 weeks of treatment in monthly Headache Impact Test-6 (HIT-6) questionnaire [ Time Frame: Baseline to Day 84 ]
- Mean change from baseline to 12 weeks of treatment in monthly Migraine Specific Quality of Life questionnaire (MSQL) [ Time Frame: Baseline to Day 84 ]
- Mean change in subject recorded migraine associated symptoms: nausea/vomiting, photophobia and sonophobia. [ Time Frame: Baseline to Day 112 ]Self reported subject diary
- Difference in plasma immune biomarker levels between active and vehicle groups [ Time Frame: Baseline to Day 112 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488563

Study Director: | Judith Ng-Cashin, MD | Chief Medical Officer |
Responsible Party: | AOBiome LLC |
ClinicalTrials.gov Identifier: | NCT03488563 |
Other Study ID Numbers: |
MGB244-001 |
First Posted: | April 5, 2018 Key Record Dates |
Last Update Posted: | July 30, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Headache |
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |