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

NCT ID: NCT03488563

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 313 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-30
• Study Completion Date: 2019-07-16

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.

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

B244 Dose 1

B244 1X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day

Group Type: EXPERIMENTAL

B244

Intervention Type: BIOLOGICAL

B244 Suspension

B244 Dose 2

B244 4X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day

Group Type: EXPERIMENTAL

B244

Intervention Type: BIOLOGICAL

B244 Suspension

Vehicle

Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: BIOLOGICAL

Vehicle Suspension

Interventions

B244

B244 Suspension

Intervention Type: BIOLOGICAL

Vehicle

Vehicle Suspension

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Veristat, Inc.

OTHER

Sponsor Role: collaborator

AOBiome LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith Ng-Cashin, MD

Role: STUDY_DIRECTOR

Chief Medical Officer

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MGB244-001

Identifier Type: -

Identifier Source: org_study_id