NCT04547179

Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Manhattan Beach Orthodontics · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Fremanezumab-Vfrm	Patients will receive three injections of Ajovy® if in the corresponding arm of the study.
DEVICE	BLAfit®	Usage of the BLAfit device, a fixed orthotic appliance that allows users to tone facial muscles with one minute usage per day
OTHER	Saline	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-04-15
• Completion: 2021-12-01
• First posted: 2020-09-14
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States