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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 : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Sunitha Bharadia, Manhattan Beach Orthodontics

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Fremanezumab-Vfrm Device: BLAfit® Other: Saline Not Applicable

Detailed Description:
We 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, we 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, we will have 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, we will also 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine Orthodontia

Arm Intervention/treatment
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.
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 Names:
  • Bella Lip Appliance®
  • BLA®

Experimental: 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.
Drug: Fremanezumab-Vfrm
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.
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.
Other Name: salt and water solution




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Maryam Bakhtiyari, DDS 3103726600 drmaryamb@aol.com
Contact: Sunitha Bharadia, MD (310) 370-4700 sbbrainmd@yahoo.com

Locations
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United States, California
Manhattan Beach Orthodontics
Manhattan Beach, California, United States, 90266
Contact: Maryam Bakhtiyari, DDS    310-372-6600      
Sponsors and Collaborators
Manhattan Beach Orthodontics
Investigators
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Principal Investigator: Sunitha Bharadia, MD Manhattan Beach Orthodontics
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Responsible Party: Dr. Sunitha Bharadia, PI, Manhattan Beach Orthodontics
ClinicalTrials.gov Identifier: NCT04547179    
Other Study ID Numbers: 0001
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dr. Sunitha Bharadia, Manhattan Beach Orthodontics:
Migraine, Ajovy, facial exercise
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erenumab
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs