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

NCT04547179 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Manhattan Beach Orthodontics

    lead OTHER

Principal Investigators

  • Sunitha Bharadia, MD · Manhattan Beach Orthodontics

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-04-15
Completion
2021-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04547179 on ClinicalTrials.gov