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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
Those eligible to participate must be between the ages of 18 to 55 years.
The individual must experience at least 2 migraines per week.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months after start
Awards & highlights
Study Summary
This study is evaluating whether a facial exercise device may help reduce migraine symptoms.
Eligible Conditions
- Migraine
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months after start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months after start
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Frequently Asked Questions
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