This small study is to investigate the efficacy of Acthar in the treatment of chronic migraine in patients who have failed multiple treatments, including Botox (which is defined as having \<30% reduction from baseline in the number of headache days per month). Despite the widespread use of anti-seizure medications, there remain a significant number of patient whose migraines are refractory to these agents. The pathophysiology of migraine is such that the neural substances calcitonin G related protein (CGRP), substance P, and neurokinin A are released at the trigeminal nerve endings innervating the large cranial and dura mater blood vessels and this neurotrasmission generates migraine associated pain. Because of this, treatment for migraine can be directed towards down regulating those receptor sites accordingly. Acthar may provide pain relief through this mechanist, as ACTH has been shown to inhibit the release of CGRP and may also provide relief through a negative feedback loop as exogenous ACTH inhibits CRH release and mast cell degranulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Acthar (40IU or 80IU) given subcutaneously for 5 days in the 1st week, followed by every other day (3 times per week for the next 3 weeks)
Clinvest/A Division of Banyan Group, Inc.
Springfield, Missouri, United States
Renown Institute of Neurosciences
Reno, Nevada, United States
Dent Neurologic Institute
Amherst, New York, United States
Baylor University Medical Center
Dallas, Texas, United States
Average total number of headache days (both 40IU and 80IU groups)
Comparison of the average total number of headache days after 30 days of Acthar treatment (both 40IU and 80IU groups)with the average number of headache days at baseline screening period
Time frame: After 30 days of treatment
Total number of headache days (both 40IU and 80IU groups)
Comparison of the total number of headache days after 30 days of Acthar treatment (both 40IU and 80IU groups) with the number of headache days at baseline screening period
Time frame: After 30 days of treatment
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