MigrainePhase 2NCT03488563
Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine
A Phase 2 study testing B244 in people with Migraine, run by AOBiome LLC at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- B244
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 313 participants
- Where
- 22 sitesUnited States
- Study dates
- 30 Mar 2018to 16 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
FutureSearch Trials of Neurology and Sleep Lab, L.P.
Austin, Texas, 78731
Charlottesville Medical Research
Charlottesville, Virginia, 22911
CTI Clinical Research Center
Cincinnati, Ohio, 45212
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231
Neurostudies Clinical Research
Decatur, Georgia, 30033
Texas Center for Drug Development
Houston, Texas, 77081
Clinical Neuroscience Solution, Inc
Jacksonville, Florida, 32256
Altea Research Institute
Las Vegas, Nevada, 89102
Precision Clinical Research
Lauderdale Lakes, Florida, 33319
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
Clinical Neuroscience Solution, Inc
Memphis, Tennessee, 38119
BTC of New Bedford
New Bedford, Massachusetts, 02740
Coastal Carolina Research Center
North Charleston, South Carolina, 29406
Clinical Neuroscience Solution, Inc
Orlando, Florida, 32801
CI Trials
Riverside, California, 92506
Rochester Clinical Research INC
Rochester, New York, 14609
Neurological Research Institute
Santa Monica, California, 90404
New England Institute for Neurology and Headache (NEINH)/Medical Practice
Stamford, Connecticut, 06905
MedVadis Research
Watertown, Massachusetts, 02472
Palm Beach Research
West Palm Beach, Florida, 33409
PMG Research of Wilmington
Wilmington, North Carolina, 28401
About this study
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
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B244Biological
B244 Suspension
VehicleBiological
Vehicle Suspension
| Study group | Role | What they receive |
|---|---|---|
| B244 Dose 1 | Experimental | B244 1X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Receives: Biological: B244 |
| B244 Dose 2 | Experimental | B244 4X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Receives: Biological: B244 |
| Vehicle | Placebo comparator | Vehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day Receives: Biological: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 112
Secondary outcomes (8)
Mean Change in Monthly Migraine Days.
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).
Measured: Baseline to Day 84
Mean Change in Monthly Migraine Attacks.
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.)
Measured: Baseline to Day 84
Proportion of Subjects Experiencing a 50%, 75%, and 100% Reduction in Monthly Migraine Days.
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).
Measured: Baseline to Day 112
Mean Change in Monthly Acute Migraine Specific Medication Days.
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.
Measured: Baseline to Day 84
Mean Change in Monthly Headache Days.
Subjects made daily entries to include recordings of migraine frequency, duration, and severity that included information on headache days (a non-migraine headache day)
Measured: Baseline to Day 84
Mean Change From Baseline to 12 Weeks of Treatment in Disability, as Measured by the Migraine Disability Assessment (MIDAS)
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.
Measured: Baseline to Day 84
Mean Change From Baseline to 12 Weeks of Treatment in Monthly Headache Impact Test-6 (HIT-6) Questionnaire
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+).
Measured: Baseline to Day 84
Mean Change From Baseline to 12 Weeks of Treatment in Monthly Migraine Specific Quality of Life Questionnaire (MSQL)
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.
Measured: Baseline to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start30 Mar 2018
- Primary completion17 Jun 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOBiome LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc.
- Responsible party
- Sponsor
- Investigators
- Judith Ng-Cashin, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488563
- Sponsor's protocol ID
- MGB244-001
- Status last verified
- Sep 2022
- First submitted
- 26 Mar 2018
- Last updated
- 4 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03488563
- Acronym / sponsor ID
- MGB244-001
- Conditions
- Migraine
- Keywords
- Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- AOBiome LLCIndustry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc.
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Posted 4 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomization will be 1:1:1 so that equal number of subjects will be treated in each arm of the study.
| Arm | Type | Receives |
|---|---|---|
| B244 Dose 1 | Experimental | Biological: B244B244 1X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day |
| B244 Dose 2 | Experimental | Biological: B244B244 4X suspension in 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day |
| Vehicle | Placebo comparator | Biological: VehicleVehicle, 30ml/bottle Subjects will apply 1 pump per nostril twice-a-day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B244B244 Suspension | Biological | B244 Dose 1, B244 Dose 2 |
| VehicleVehicle Suspension | Biological | Vehicle |
Primary outcome
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.
8 secondary outcomes
Mean Change in Monthly Migraine Days.
Time frame: Baseline to Day 84
Mean Change in Monthly Migraine Attacks.
Time frame: Baseline to Day 84
Proportion of Subjects Experiencing a 50%, 75%, and 100% Reduction in Monthly Migraine Days.
Time frame: Baseline to Day 112
Mean Change in Monthly Acute Migraine Specific Medication Days.
Time frame: Baseline to Day 84
Mean Change in Monthly Headache Days.
Time frame: 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
Mean Change From Baseline to 12 Weeks of Treatment in Monthly Headache Impact Test-6 (HIT-6) Questionnaire
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Ng-Cashin, MD study director
Chief Medical Officer
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing B244 in people with Migraine, run by AOBiome LLC at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (time frame: Baseline to Day 112). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.