Chronic Migraine, Headache Clinical Trial
Official title:
A Multi-Center Unblinded Proof-of-Concept Study of DaxibotulinumtoxinA for Migraine Prevention in High-Frequency and Chronic Migraine: the Standard Paradigm
This is a prospective, multi-center, unblinded study in patients with migraine (≥ 8 MMDs/month) requiring preventive treatment. Enrolled patients will receive DAX administered subcutaneously using an established, published, legacy injection paradigm (referred to herein as the "standard paradigm"). The safety and efficacy outcome measures will be assessed at selected dosing segments during the 24-week treatment phase.
Patients enrolled who meet eligibility will receive a total of 310 units of DAXI Injections in divided doses over 31 landmarks (sites), including the face, head, neck and shoulders, as identified per the standard paradigm, at visit 2. Follow-up visits via combination of phone and in office will occur at V3, week 8, through V9, week 24. ;
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