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

NCT ID: NCT04547179

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-12-01

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.

Conditions

Migraine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

BLAfit®

Intervention Type: DEVICE

Usage of the BLAfit device, a fixed orthotic appliance that allows users to tone facial muscles with one minute usage per day

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.

Group Type: EXPERIMENTAL

Fremanezumab-Vfrm

Intervention Type: DRUG

Patients will receive three injections of Ajovy® if in the corresponding arm of the study.

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

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.

Interventions

Fremanezumab-Vfrm

Patients will receive three injections of Ajovy® if in the corresponding arm of the study.

Intervention Type: DRUG

BLAfit®

Usage of the BLAfit device, a fixed orthotic appliance that allows users to tone facial muscles with one minute usage per day

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Ajovy®; Bella Lip Appliance®; BLA®; salt and water solution

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Manhattan Beach Orthodontics

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sunitha Bharadia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunitha Bharadia, MD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Beach Orthodontics

Locations

Manhattan Beach Orthodontics

Manhattan Beach, California, United States

Countries

United States

Central Contacts

Maryam Bakhtiyari, DDS

Role: CONTACT

drmaryamb@aol.com

3103726600

Sunitha Bharadia, MD

Role: CONTACT

sbbrainmd@yahoo.com

(310) 370-4700

Facility Contacts

Maryam Bakhtiyari, DDS

Role: primary

310-372-6600

Other Identifiers

0001

Identifier Type: -

Identifier Source: org_study_id