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BLAfit® usage for Migraine

N/A
Waitlist Available
Led By Sunitha Bharadia, MD
Research Sponsored by Manhattan Beach Orthodontics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months after start
Awards & highlights

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.

Eligible Conditions
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months after start
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months after start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency and Pain Level of Migraines Post-Treatment

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: fremanezumab-vfrmExperimental Treatment1 Intervention
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.
Group II: BLAfit® usageExperimental Treatment1 Intervention
In this arm, subjects will used the fixed orthotic device called BLAfit® for one minute of facial exercise a day for three months.
Group III: Saline injectionPlacebo Group1 Intervention
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.

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Who is running the clinical trial?

Manhattan Beach OrthodonticsLead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Sunitha Bharadia, MDPrincipal InvestigatorManhattan Beach Orthodontics
~17 spots leftby Sep 2025
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