Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04547179|
Recruitment Status : Not yet recruiting
First Posted : September 14, 2020
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Fremanezumab-Vfrm Device: BLAfit® Other: Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study|
|Estimated Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||April 15, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: 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.
Usage of the BLAfit device, a fixed orthotic appliance that allows users to tone facial muscles with one minute usage per day
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.
Patients will receive three injections of Ajovy® if in the corresponding arm of the study.
Other Name: Ajovy®
Placebo Comparator: 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.
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.
Other Name: salt and water solution
- Frequency and Pain Level of Migraines Post-Treatment [ Time Frame: 4 months after start ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547179
|Contact: Maryam Bakhtiyari, DDSemail@example.com|
|Contact: Sunitha Bharadia, MD||(310) firstname.lastname@example.org|
|United States, California|
|Manhattan Beach Orthodontics|
|Manhattan Beach, California, United States, 90266|
|Contact: Maryam Bakhtiyari, DDS 310-372-6600|
|Principal Investigator:||Sunitha Bharadia, MD||Manhattan Beach Orthodontics|