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

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ClinicalTrials.gov Identifier: NCT03488563
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Veristat, Inc.
Information provided by (Responsible Party):
AOBiome LLC

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 303 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
Estimated Primary Completion Date : November 20, 2018
Estimated Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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.

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


Contacts
Contact: Hyun Kim 6174013191 hkim@aobiome.com
Contact: Alissa Lacy 6174013191 alacy@aobiome.com

Locations
United States, Arkansas
Baptist Health Center for Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Lauren Evans       LREvans@bhccr.com   
United States, California
Collaborative Neuroscience Network, LLC Recruiting
Long Beach, California, United States, 90806
Contact: Anne Cabral       annecabral@cnstrial.com   
CI Trials Recruiting
Riverside, California, United States, 92506
Contact: Nelly Mata       Nelly.mata@citrials.com   
Neurological Research Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Haesoo Jeon       hjeon@drkudrow.com   
Principal Investigator: David Kudrow         
United States, Connecticut
New England Institute for Neurology and Headache (NEINH)/Medical Practice Recruiting
Stamford, Connecticut, United States, 06905
Contact: Grace Valentin       grace@neicr.com   
United States, Florida
Palm Beach Research Recruiting
West Palm Beach, Florida, United States, 33409
Contact: Mary Sergalis       mary@palmbeachresearch.com   
United States, Georgia
Neurostudies Clinical Research Not yet recruiting
Decatur, Georgia, United States, 30033
Contact: Sherry Myers       smyers@neurostudies.net   
United States, Massachusetts
BTC of New Bedford Recruiting
New Bedford, Massachusetts, United States, 02740
Contact: Heather Ferreria       heather@btcsites.com   
MedVadis Research Recruiting
Watertown, Massachusetts, United States, 02472
Contact: Silpa Mohapatra       Mohapatra@medvadis.com   
Principal Investigator: Egillus Spierings         
United States, Nevada
Altea Research Institute Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Natalie Schwebel       nschwebel@altearesearch.com   
United States, New York
Rochester Clinical Research INC Recruiting
Rochester, New York, United States, 14609
Contact: Jaclyn Zona       jzona@rcrclinical.com   
United States, Ohio
CTI Clinical Research Center Recruiting
Cincinnati, Ohio, United States, 45212
Contact: Katie Thompson       kthompson@ctifacts.com   
United States, Texas
FutureSearch Trials of Neurology and Sleep Lab, L.P. Recruiting
Austin, Texas, United States, 78731
Contact: Kevin Ford       kevinf@fstrials.com   
Texas Center for Drug Development Recruiting
Houston, Texas, United States, 77081
Contact: Cherrylyn Khaykin       cherry.khaykin@tcddresearch.com   
United States, Virginia
Charlottesville Medical Research Recruiting
Charlottesville, Virginia, United States, 22911
Contact: Penny Amos       penny@cvillemedresearch.com   
Sponsors and Collaborators
AOBiome LLC
Veristat, Inc.
Investigators
Study Director: Larry Weiss, MD Chief Medical Officer

Additional Information:
Responsible Party: AOBiome LLC
ClinicalTrials.gov Identifier: NCT03488563     History of Changes
Other Study ID Numbers: MGB244-001
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
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

Keywords provided by AOBiome LLC:
Headache

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases