NCT04547179

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

September 7, 2020

Last Update Submit

January 18, 2021

Conditions

Migraine

Keywords

MigraineAjovyfacial exercisefremanezumab-vfrm

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

BLAfit® usage

EXPERIMENTAL

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®

fremanezumab-vfrm

EXPERIMENTAL

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

Saline injection

PLACEBO COMPARATOR

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

Interventions

Fremanezumab-VfrmDRUG

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

Also known as: Ajovy®
fremanezumab-vfrm
BLAfit®DEVICE

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

Also known as: Bella Lip Appliance®, BLA®
BLAfit® usage
SalineOTHER

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.

Also known as: salt and water solution
Saline injection

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Beach Orthodontics

Manhattan Beach, California, 90266, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumabSodium ChlorideSalts

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Sunitha Bharadia, MD

    Manhattan Beach Orthodontics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Bakhtiyari, DDS

CONTACT

3103726600drmaryamb@aol.com

Sunitha Bharadia, MD

CONTACT

(310) 370-4700sbbrainmd@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

February 1, 2021

Primary Completion

April 15, 2021

Study Completion

December 1, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)