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

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
Sponsor:
Collaborator:
Veristat, Inc.
Information provided by (Responsible Party):
AOBiome LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Biological: B244 Biological: Vehicle Phase 2

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: B244 Dose 1
B244 1X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
 Biological: B244
B244 Suspension
Experimental: B244 Dose 2
B244 4X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
 Biological: B244
B244 Suspension
Placebo Comparator: Vehicle
Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
 Biological: Vehicle
Vehicle Suspension


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mean change in monthly migraine days. [ Time Frame: Baseline to Day 84 ]
  2. Mean change in monthly migraine attacks. [ Time Frame: Baseline to Day 84 ]
  3. Proportion of subjects experiencing a 50%, 75%, and 100% reduction in monthly migraine days. [ Time Frame: Baseline to Day 112 ]
  4. Mean change in monthly acute migraine specific medication days. [ Time Frame: Baseline to Day 84 ]
  5. 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 ]
  6. Mean change from baseline to 12 weeks of treatment in monthly Headache Impact Test-6 (HIT-6) questionnaire [ Time Frame: Baseline to Day 84 ]
  7. Mean change from baseline to 12 weeks of treatment in monthly Migraine Specific Quality of Life questionnaire (MSQL) [ Time Frame: Baseline to Day 84 ]

Other Outcome Measures:
  1. Mean change in subject recorded migraine associated symptoms: nausea/vomiting, photophobia and sonophobia. [ Time Frame: Baseline to Day 112 ]
    Self reported subject diary

  2. Difference in plasma immune biomarker levels between active and vehicle groups [ Time Frame: Baseline to Day 112 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
AOBiome LLC
Veristat, Inc.
Investigators
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Study Director: Judith Ng-Cashin, MD Chief Medical Officer
More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AOBiome LLC:
Headache
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases