MigraineNCT04547179
Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study
A study testing Fremanezumab-Vfrm, BLAfit® and Saline in people with Migraine, run by Manhattan Beach Orthodontics at 1 site in United States.
Trial summary
To understand the impacts of using a fixed orthotic facial exercise appliance (BLAfit®) for migraine reduction, as compared to medication (fremanezumab-vfrm) and control. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Fremanezumab-Vfrm, BLAfit® and Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those eligible to participate must be between the ages of 18 to 55 years.
- The individual must experience at least 2 migraines per week.
- They must be capable of visiting the medical facility in Manhattan Beach, California where the in-person screening and final evaluation will be conducted (following COVID-19 public health guidelines).
- They must be able to communicate with the study team via any teleconferencing service such as Zoom, Google Hangouts, or FaceTime.
Who cannot join
- Patients must not have any intracranial pathology, neurological or psychological conditions, epilepsy, cancer, any history of chemotherapy, hospitalized for depression, psychiatric conditions, seizures, or tumors.
- Patients cannot have taken Botox® for migraine treatments.
- Patients cannot have had a history of head or neck surgery.
- Patients cannot be taking: propranolol, amitriptyline, flunarizine, topiramate, combination, galcanezumab-gnlm, fremanezumab-vfrm, or erenumab-aooe.
- Patients must not be deemed a vulnerable subject (including but not limited to: children, prisoners, pregnant women, mentally disabled persons).
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Beach Orthodontics
Manhattan Beach, California, 90266
Maryam Bakhtiyari, DDS, 310-372-6600
About this study
To understand the impacts of using a fixed orthotic facial exercise appliance (BLAfit®) for migraine reduction, as compared to medication (fremanezumab-vfrm) and control.
Read the detailed description
The investigators will be studying the impacts of using an orthotic facial exercise device (BLAfit®) in the prevention of migraines for those who suffer from roughly 10-15 migraines per month. In order to test the efficacy of this device and its exercise routine, investigators will have one arm of our study receive the BLAfit® device and perform the exercises for one minute daily for three months. In Arm #2, there will be another treatment: Ajovy® (fremanezumab-vfrm) injections- which is a known and commonly practiced clinical prevention treatment for migraine patients. Patients in this arm will receive three injections of Ajovy, which is will be meant to last 3 months. In addition, investigators will have a placebo group that will receive three saline injections, which are meant to mimic the three Ajovy® injections. Arms #2 and #3 of this study will be conducted in a double-blind fashion, as both the clinician providing the injections and the patients receiving the injections will not know if the injecting substance is Ajovy or saline, so as to minimize bias. All patients in all three months will log their number and pain level of their migraines each day for three months. Upon conclusion, they will meet with our in-house neurologist (Principal Investigator \& Sponsor) for a final in-person evaluation and questionnaire. Results from the three groups will then be analyzed.
- Conditions
- Migraine
- Being tested
- Fremanezumab-Vfrm, BLAfit®, Saline
- Keywords
- Migraine, Ajovy, facial exercise, fremanezumab-vfrm
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fremanezumab-VfrmDrug
Also called Ajovy®
Patients will receive three injections of Ajovy® if in the corresponding arm of the study.
BLAfit®Device
Also called Bella Lip Appliance®, BLA®
Usage of the BLAfit device, a fixed orthotic appliance that allows users to tone facial muscles with one minute usage per day
SalineOther
Also called salt and water solution
Patients will receive three injections of saline if in the corresponding arm of the study. This is a placebo meant to simulate the Ajovy® injection.
| Study group | Role | What they receive |
|---|---|---|
| BLAfit® usage | Experimental | In this arm, subjects will used the fixed orthotic device called BLAfit® for one minute of facial exercise a day for three months. Receives: Device: BLAfit® |
| fremanezumab-vfrm | Experimental | Subjects in this arm will receive three Ajovy® (fremanezumab-vfrm) injections at the start of month 2. This will be conducted in a double-blind fashion, as both the clinician providing the injection, and the subject, will not know if the injection is actually Ajovy® or just saline. Receives: Drug: Fremanezumab-Vfrm |
| Saline injection | Placebo comparator | This is a placebo that is used to counter Arm #2- the Ajovy® injections. Subjects in this arm will receive three saline injections at the start of month 2 that will mimic the Ajovy® injections. This will be conducted in a double-blind fashion, as both the clinician providing the injection, and the subject, will not know if the injection is actually Ajovy® or just saline. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Pain Level of Migraines Post-Treatment
The frequency and pain level of subjects' migraines will be assessed upon the conclusion of the study through surveying and comparing to previous survey data.
Measured: 4 months after start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Feb 2021 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manhattan Beach Orthodontics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sunitha Bharadia, Manhattan Beach Orthodontics
- Investigators
- Sunitha Bharadia, MD, Principal investigator, Manhattan Beach Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547179
- Sponsor's protocol ID
- 0001
- Status last verified
- Jan 2021
- First submitted
- 7 Sep 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study
- ClinicalTrials.gov ID
- NCT04547179
- Acronym / sponsor ID
- 0001
- Conditions
- Migraine
- Keywords
- Migraine, Ajovy, facial exercise, fremanezumab-vfrm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Manhattan Beach OrthodonticsUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To understand the impacts of using a fixed orthotic facial exercise appliance (BLAfit®) for migraine reduction, as compared to medication (fremanezumab-vfrm) and control.
Detailed description
The investigators will be studying the impacts of using an orthotic facial exercise device (BLAfit®) in the prevention of migraines for those who suffer from roughly 10-15 migraines per month. In order to test the efficacy of this device and its exercise routine, investigators will have one arm of our study receive the BLAfit® device and perform the exercises for one minute daily for three months. In Arm #2, there will be another treatment: Ajovy® (fremanezumab-vfrm) injections- which is a known and commonly practiced clinical prevention treatment for migraine patients. Patients in this arm will receive three injections of Ajovy, which is will be meant to last 3 months. In addition, investigators will have a placebo group that will receive three saline injections, which are meant to mimic the three Ajovy® injections. Arms #2 and #3 of this study will be conducted in a double-blind fashion, as both the clinician providing the injections and the patients receiving the injections will not know if the injecting substance is Ajovy or saline, so as to minimize bias. All patients in all three months will log their number and pain level of their migraines each day for three months. Upon conclusion, they will meet with our in-house neurologist (Principal Investigator \& Sponsor) for a final in-person evaluation and questionnaire. Results from the three groups will then be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLAfit® usage | Experimental | Device: BLAfit®In this arm, subjects will used the fixed orthotic device called BLAfit® for one minute of facial exercise a day for three months. |
| fremanezumab-vfrm | Experimental | Drug: Fremanezumab-VfrmSubjects in this arm will receive three Ajovy® (fremanezumab-vfrm) injections at the start of month 2. This will be conducted in a double-blind fashion, as both the clinician providing the injection, and the subject, will not know if the injection is actually Ajovy® or just saline. |
| Saline injection | Placebo comparator | Other: SalineThis is a placebo that is used to counter Arm #2- the Ajovy® injections. Subjects in this arm will receive three saline injections at the start of month 2 that will mimic the Ajovy® injections. This will be conducted in a double-blind fashion, as both the clinician providing the injection, and the subject, will not know if the injection is actually Ajovy® or just saline. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Those eligible to participate must be between the ages of 18 to 55 years.
- The individual must experience at least 2 migraines per week.
- They must be capable of visiting the medical facility in Manhattan Beach, California where the in-person screening and final evaluation will be conducted (following COVID-19 public health guidelines).
- They must be able to communicate with the study team via any teleconferencing service such as Zoom, Google Hangouts, or FaceTime.
Key exclusion criteria (5 listed)
- Patients must not have any intracranial pathology, neurological or psychological conditions, epilepsy, cancer, any history of chemotherapy, hospitalized for depression, psychiatric conditions, seizures, or tumors.
- Patients cannot have taken Botox® for migraine treatments.
- Patients cannot have had a history of head or neck surgery.
- Patients cannot be taking: propranolol, amitriptyline, flunarizine, topiramate, combination, galcanezumab-gnlm, fremanezumab-vfrm, or erenumab-aooe.
- Patients must not be deemed a vulnerable subject (including but not limited to: children, prisoners, pregnant women, mentally disabled persons).
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 |
|---|---|---|
| Fremanezumab-VfrmAlso: Ajovy®Patients will receive three injections of Ajovy® if in the corresponding arm of the study. | Drug | fremanezumab-vfrm |
| BLAfit®Also: Bella Lip Appliance®, BLA®Usage of the BLAfit device, a fixed orthotic appliance that allows users to tone facial muscles with one minute usage per day | Device | BLAfit® usage |
| SalineAlso: salt and water solutionPatients will receive three injections of saline if in the corresponding arm of the study. This is a placebo meant to simulate the Ajovy® injection. | Other | Saline injection |
Primary outcome
Frequency and Pain Level of Migraines Post-Treatment
Time frame: 4 months after start
The frequency and pain level of subjects' migraines will be assessed upon the conclusion of the study through surveying and comparing to previous survey data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- 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.
Sunitha Bharadia, MD principal investigator
Manhattan Beach Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fremanezumab-Vfrm, BLAfit® and Saline in people with Migraine, run by Manhattan Beach Orthodontics at 1 site 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maryam Bakhtiyari, DDS (3103726600, drmaryamb@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and Pain Level of Migraines Post-Treatment (time frame: 4 months after start). 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 22 Jan 2021.