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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Migraine

In brief

To understand the impacts of using a fixed orthotic facial exercise appliance (BLAfit®) for migraine reduction, as compared to medication (fremanezumab-vfrm) and control.

Key facts

Study ID: NCT04547179
Run by: Manhattan Beach Orthodontics
People needed: 80
Starts: 2021-02-01
Expected to finish: 2021-12-01
Last updated by the study team: 2021-01-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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).

Where it is running

Manhattan Beach Orthodontics — Manhattan Beach, California, United States

Full record on ClinicalTrials.gov

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