Clinical trial NCT04547179: Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study
Official title: Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Keywords: Migraine
Ajovy
facial exercise
fremanezumab-vfrm
Lead sponsor: Manhattan Beach Orthodontics
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Frequency and Pain Level of Migraines Post-Treatment
timeFrame: 4 months after start
Secondary outcomes:
Other outcomes:
Locations:
city: Manhattan Beach
country: United States
facility: Manhattan Beach Orthodontics
state: California
Study officials:
affiliation: Manhattan Beach Orthodontics
name: Sunitha Bharadia, MD
role: PRINCIPAL_INVESTIGATOR
References: