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

NCT03488563 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MGB244-001
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 22

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.

Conditions

Migraine

Keywords

Headache

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.

  Baseline to Day 112

Secondary Outcomes (8)

• Mean Change in Monthly Migraine Days.

  Baseline to Day 84

• Mean Change in Monthly Migraine Attacks.

  Baseline to Day 84

• Proportion of Subjects Experiencing a 50%, 75%, and 100% Reduction in Monthly Migraine Days.

  Baseline to Day 112

• Mean Change in Monthly Acute Migraine Specific Medication Days.

  Baseline to Day 84

• Mean Change in Monthly Headache Days.

  Baseline to Day 84

Other Outcomes (1)

• Mean Change in Days Where Subject Recorded Migraine Associated Symptoms: Nausea/Vomiting, Photophobia and Sonophobia.

  Baseline to Day 112

Study Arms (3)

B244 Dose 1

EXPERIMENTAL

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

Biological: B244

B244 Dose 2

EXPERIMENTAL

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

Biological: B244

Vehicle

PLACEBO COMPARATOR

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

Biological: Vehicle

Interventions

B244 BIOLOGICAL

B244 Suspension

B244 Dose 1; B244 Dose 2

Vehicle BIOLOGICAL

Vehicle Suspension

Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AOBiome LLC: lead
• Veristat, Inc.: collaborator

Study Sites (22)

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

CI Trials

Riverside, California, 92506, United States

Location

Neurological Research Institute

Santa Monica, California, 90404, United States

Location

New England Institute for Neurology and Headache (NEINH)/Medical Practice

Stamford, Connecticut, 06905, United States

Location

Clinical Neuroscience Solution, Inc

Jacksonville, Florida, 32256, United States

Location

Precision Clinical Research

Lauderdale Lakes, Florida, 33319, United States

Location

Clinical Neuroscience Solution, Inc

Orlando, Florida, 32801, United States

Location

Palm Beach Research

West Palm Beach, Florida, 33409, United States

Location

Neurostudies Clinical Research

Decatur, Georgia, 30033, United States

Location

BTC of New Bedford

New Bedford, Massachusetts, 02740, United States

Location

MedVadis Research

Watertown, Massachusetts, 02472, United States

Location

Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Rochester Clinical Research INC

Rochester, New York, 14609, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29406, United States

Location

Clinical Neuroscience Solution, Inc

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Neurology and Sleep Lab, L.P.

Austin, Texas, 78731, United States

Location

FutureSearch Trials of Dallas, L.P.

Dallas, Texas, 75231, United States

Location

Texas Center for Drug Development

Houston, Texas, 77081, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Hyun Kim, Vice President Clinical Operations
• Organization: AOBiome Therapeutics

hkim@aobiome.com

617-639-9980

Study Officials

• Judith Ng-Cashin, MD

  Chief Medical Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization will be 1:1:1 so that equal number of subjects will be treated in each arm of the study.

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 5, 2018
• Study Start: March 30, 2018
• Primary Completion: June 17, 2019
• Study Completion: July 16, 2019
• Last Updated: October 4, 2022
• Results First Posted: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)