- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03488563
Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine
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
Study Overview
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Baptist Health Center for Clinical Research
-
-
California
-
Long Beach, California, United States, 90806
- Collaborative Neuroscience Network, LLC
-
Riverside, California, United States, 92506
- CI Trials
-
Santa Monica, California, United States, 90404
- Neurological Research Institute
-
-
Connecticut
-
Stamford, Connecticut, United States, 06905
- New England Institute for Neurology and Headache (NEINH)/Medical Practice
-
-
Florida
-
Jacksonville, Florida, United States, 32256
- Clinical Neuroscience Solution, Inc
-
Lauderdale Lakes, Florida, United States, 33319
- Precision Clinical Research
-
Orlando, Florida, United States, 32801
- Clinical Neuroscience Solution, Inc
-
West Palm Beach, Florida, United States, 33409
- Palm Beach Research
-
-
Georgia
-
Decatur, Georgia, United States, 30033
- Neurostudies Clinical Research
-
-
Massachusetts
-
New Bedford, Massachusetts, United States, 02740
- BTC of New Bedford
-
Watertown, Massachusetts, United States, 02472
- MedVadis Research
-
-
Nevada
-
Las Vegas, Nevada, United States, 89102
- Altea Research Institute
-
-
New York
-
Rochester, New York, United States, 14609
- Rochester Clinical Research Inc
-
-
North Carolina
-
Wilmington, North Carolina, United States, 28401
- PMG Research of Wilmington
-
-
Ohio
-
Cincinnati, Ohio, United States, 45212
- CTI Clinical Research Center
-
-
South Carolina
-
North Charleston, South Carolina, United States, 29406
- Coastal Carolina Research Center
-
-
Tennessee
-
Memphis, Tennessee, United States, 38119
- Clinical Neuroscience Solution, Inc
-
-
Texas
-
Austin, Texas, United States, 78731
- FutureSearch Trials of Neurology and Sleep Lab, L.P.
-
Dallas, Texas, United States, 75231
- FutureSearch Trials of Dallas, L.P.
-
Houston, Texas, United States, 77081
- Texas Center for Drug Development
-
-
Virginia
-
Charlottesville, Virginia, United States, 22911
- Charlottesville Medical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B244 Dose 1
B244 1X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
|
B244 Suspension
|
Experimental: B244 Dose 2
B244 4X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
|
B244 Suspension
|
Placebo Comparator: Vehicle
Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day
|
Vehicle Suspension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to Day 112
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Monthly Migraine Days.
Time Frame: Baseline to Day 84
|
Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine days (experiencing migraine with or without aura in a given day).
|
Baseline to Day 84
|
Mean Change in Monthly Migraine Attacks.
Time Frame: Baseline to Day 84
|
Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine attacks (an episode of any qualified migraine headache. To distinguish an attack of long duration from two attacks or to distinguish between attacks and relapses: A migraine attack that is interrupted by sleep, or temporarily remits, and then recurs within 48 hours (i.e., <48 hours between the start of the migraine attack to the time of the recurrence) will be considered as one attack and not two. -An attack treated successfully with medication but with relapse within 48 hours (i.e., <48 hours between the start of the migraine attack to the time of recurrence) will be considered as one attack.) |
Baseline to Day 84
|
Proportion of Subjects Experiencing a 50%, 75%, and 100% Reduction in Monthly Migraine Days.
Time Frame: Baseline to Day 112
|
Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine days (experiencing migraine with or without aura in a given day).
|
Baseline to Day 112
|
Mean Change in Monthly Acute Migraine Specific Medication Days.
Time Frame: Baseline to Day 84
|
Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included use of rescue (acute migraine specific) medications and dosing administration.
|
Baseline to Day 84
|
Mean Change in Monthly Headache Days.
Time Frame: Baseline to Day 84
|
Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on headache days (a non-migraine headache day)
|
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
|
The Migraine Disability Assessment (MIDAS) questionnaire was administered to study examine the relationship between the impact of migraine and quality of life where subjects scored 5 questions on a scale of 0 to 21+ (0-5=little or no disability, 6-10=mild disability, 11-20=moderate disability, 21+=severe disability).
The total score ranges from 0 to 90.
|
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
|
The Headache Impact Test-6 (HIT-6) questionnaire was administered to examine the relationship between impact of migraine and quality of life.
The total score ranges from 36 to 78 where a higher score indicates a greater impact on quality of life (Class I: 36-49, Class II: 50-55, Class III: 56-59, Class IV: 60+).
|
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
|
The Migraine Specific Quality of Life (MSQL) questionnaire was used to examine the impact of migraine on health-related quality of life across three domains: Role Function-Restrictive (7 questions) examines the degree to which performance of daily activities is limited by migraine; Role Function-Preventive (4 questions) examines the degree to which performance of daily activities is prevented by migraine; Emotional Function (3 questions) examines feelings of frustration and helplessness due to migraine.
Total score for each domain ranges from 0 to 100, where a higher score indicates greater severity.
|
Baseline to Day 84
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Days Where Subject Recorded Migraine Associated Symptoms: Nausea/Vomiting, Photophobia and Sonophobia.
Time Frame: Baseline to Day 112
|
Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on migraine associated symptoms: nausea/vomiting, photophobia and sonophobia.
|
Baseline to Day 112
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MGB244-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
-
Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on B244
-
AOBiome LLCVeristat, Inc.CompletedAtopic Dermatitis EczemaUnited States
-
AOBiome LLCVeristat, Inc.CompletedPrehypertension | Hypertension, Stage IUnited States
-
AOBiome LLCNovella ClinicalCompletedEczema | Atopic DermatitisUnited States
-
AOBiome LLCIntegrium; Orange County Research CenterCompletedAllergic Rhinitis Due to Grass Pollen | Allergic Rhinitis | Healthy VolunteersUnited States, Canada
-
AOBiome LLCbioRASI, LLCCompletedAtopic DermatitisUnited States
-
AOBiome LLCbioRASI, LLCCompleted
-
AOBiome LLCCompleted
-
AOBiome LLCCompletedAcne VulgarisUnited States