Manhattan Beach Orthodontics
Dr. Sunitha Bhardiya
To understand the impacts of using a fixed orthotic facial exercise appliance (BLAfit®) for migraine reduction, as compared to medication (fremanezumab-vfrm) and control.
Migraine
Fremanezumab-Vfrm
BLAfit®
Saline
Not Applicable
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 Type : | Interventional |
Estimated Enrollment : | 80 participants |
Masking : | Double |
Primary Purpose : | Prevention |
Official Title : | Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study |
Actual Study Start Date : | February 1, 2021 |
Estimated Primary Completion Date : | April 15, 2021 |
Estimated Study Completion Date : | December 1, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: BLAfit® usage In this arm, subjects will used the fixed orthotic device called BLAfit® for one minute of facial exercise a day for three months. |
Device: BLAfit® |
Experimental: fremanezumab-vfrm 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. |
Drug: Fremanezumab-Vfrm |
Placebo Comparator: Saline injection 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. |
Other: Saline |
Ages Eligible for Study: | 18 Years to 55 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Manhattan Beach Orthodontics
Manhattan Beach, California, United States, 90266