## Protocol Section
### Identification Module
**NCT ID:** NCT04547179

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

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

#### Organization Study ID Info
**ID:** 0001
#### Organization
**Class:** OTHER
**Full Name:** Manhattan Beach Orthodontics
### Status Module
#### Completion Date
**Date:** 2021-12-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-01-22

**Type:** ACTUAL

**Last Update Submit Date:** 2021-01-18

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-04-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-01

**Type:** ESTIMATED

**Status Verified Date:** 2021-01

#### Study First Post Date
**Date:** 2020-09-14
**Type:** ACTUAL
**Study First Submit Date:** 2020-09-07
**Study First Submit QC Date:** 2020-09-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Manhattan Beach Orthodontics

#### Responsible Party

**Investigator Affiliation:** Manhattan Beach Orthodontics

**Investigator Full Name:** Dr. Sunitha Bharadia

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Migraine

**Keywords:**

- Migraine

- Ajovy

- facial exercise

- fremanezumab-vfrm

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In this arm, subjects will used the fixed orthotic device called BLAfit® for one minute of facial exercise a day for three months.

**Intervention Names:**

- Device: BLAfit®

**Label:** BLAfit® usage

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: Fremanezumab-Vfrm

**Label:** fremanezumab-vfrm

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 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.

**Intervention Names:**

- Other: Saline

**Label:** Saline injection

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- fremanezumab-vfrm

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

**Name:** Fremanezumab-Vfrm

**Other Names:**

- Ajovy®

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- BLAfit® usage

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

**Name:** BLAfit®

**Other Names:**

- Bella Lip Appliance®

- BLA®

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- Saline injection

**Description:** 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.

**Name:** Saline

**Other Names:**

- salt and water solution

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Frequency and Pain Level of Migraines Post-Treatment

**Time Frame:** 4 months after start

### Eligibility Module

**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).

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drmaryamb@aol.com

**Name:** Maryam Bakhtiyari, DDS

**Phone:** 3103726600

**Role:** CONTACT

**Contact 2:**

**Email:** sbbrainmd@yahoo.com

**Name:** Sunitha Bharadia, MD

**Phone:** (310) 370-4700

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Manhattan Beach

**Contacts:**

***Contact 1:***

- **Name:** Maryam Bakhtiyari, DDS

- **Phone:** 310-372-6600

- **Role:** CONTACT

**Country:** United States

**Facility:** Manhattan Beach Orthodontics

**State:** California

**Zip:** 90266

#### Overall Officials

**Official 1:**

**Affiliation:** Manhattan Beach Orthodontics

**Name:** Sunitha Bharadia, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000051270

- Term: Headache Disorders, Primary

- ID: D000020773

- Term: Headache Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M11852

- Name: Migraine Disorders

- Relevance: HIGH

- As Found: Migraine

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

- ID: M9351

- Name: Headache

- Relevance: LOW

- As Found: Unknown

- ID: M22529

- Name: Headache Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M26657

- Name: Headache Disorders, Primary

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008881

- Term: Migraine Disorders

### Intervention Browse Module - Ancestors

- ID: D000077221

- Term: Calcitonin Gene-Related Peptide Receptor Antagonists

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: VaDiAg

- Name: Vasodilator Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M269877

- Name: Erenumab

- Relevance: HIGH

- As Found: Extra-hepatic

- ID: M5379

- Name: Calcitonin

- Relevance: LOW

- As Found: Unknown

- ID: M260622

- Name: Salmon calcitonin

- Relevance: LOW

- As Found: Unknown

- ID: M18305

- Name: Calcitonin Gene-Related Peptide

- Relevance: LOW

- As Found: Unknown

- ID: M254422

- Name: Katacalcin

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000605816

- Term: Erenumab

### Misc Info Module

- Version Holder: 2024-05-24
