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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04547179
• Other study ID #: 0001
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2021
• Source: Manhattan Beach Orthodontics
• Contact: Maryam Bakhtiyari, DDS
• Phone: 3103726600
• Email: drmaryamb[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Manhattan Beach Orthodontics	Manhattan Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Manhattan Beach Orthodontics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months after start